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1.
Retina ; 44(7): 1165-1170, 2024 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-38900578

RESUMO

BACKGROUND/PURPOSE: To determine and compare the efficacy of a surgical internal limiting membrane (ILM) flap technique with the traditional ILM peel on long-term visual and anatomical outcomes for large (>400 µm) full-thickness macular holes. METHODS: From October 2016 to July 2022, patients undergoing initial full-thickness macular hole repair with the ILM flap or ILM peel technique were reviewed. Final outcomes were recorded and based on size in microns: 401 to 800, 801 to 1,200, and >1,200. RESULTS: Patients treated with ILM flap (n = 52, 94.2% closure rate) or ILM peel (n = 407, 93.6% closure rate) were followed with a mean follow-up time of 15.0 ± 10.2 and 20.0 ± 13.4 months, respectively. Success rates for ILM flaps and ILM peels were compared for full-thickness macular holes of 401 to 800 (100%, 95.8%, P = 0.39), 801 to 1,200 (95%, 93%, P = 0.74), and >1,200 (86.7%, 86.7%, P = 1.0) µm. Mean best-recorded logarithm of the minimal angle of resolution visual acuity for ILM flaps and ILM peels, respectively, was 1.02 ± 0.46 and 0.87 ± 0.47 preoperatively, with follow-up acuity of 0.48 ± 0.32 (P < 0.03) and 0.39 ± 0.42 (P < 0.01) at Year 3. CONCLUSION: Both techniques provide a similar anatomical closure rate and functional improvement in vision. Comparisons should be cautiously made based on difference in preoperative hole size.


Assuntos
Membrana Basal , Perfurações Retinianas , Retalhos Cirúrgicos , Tomografia de Coerência Óptica , Acuidade Visual , Vitrectomia , Humanos , Perfurações Retinianas/cirurgia , Perfurações Retinianas/fisiopatologia , Feminino , Membrana Basal/cirurgia , Masculino , Acuidade Visual/fisiologia , Vitrectomia/métodos , Estudos Retrospectivos , Idoso , Seguimentos , Pessoa de Meia-Idade , Resultado do Tratamento , Tamponamento Interno/métodos , Fatores de Tempo , Membrana Epirretiniana/cirurgia
2.
Ophthalmol Retina ; 6(5): 339-346, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35074559

RESUMO

PURPOSE: To assess outcomes among eyes undergoing surgery for recurrent rhegmatogenous retinal detachment (RRD) and investigate variables that correlate with visual and anatomic outcomes. DESIGN: Retrospective, consecutive case series. PARTICIPANTS: Eyes in which initial RRD repair failed that underwent ≥2 surgeries for RRD repair between January 1, 2016, and December 31, 2020. METHODS: A retrospective analysis of eyes that underwent ≥2 RRD repairs. Eyes with etiologies of retinal detachment other than RRD, previous vitreoretinal surgery, and proliferative diabetic retinopathy were excluded. One-way analysis of variance with Tukey honestly significant difference testing and multivariate regression analyses were used to assess statistical significance. MAIN OUTCOME MEASURES: Anatomic success rate and habitual best recorded visual acuity (VA) at postoperative time intervals and at final follow-up. RESULTS: The single-operation success rate (SOSR) among eyes that underwent primary RRD repair over a 5-year period was 92.4% (2021 of 2187 eyes). The remaining 166 eyes (164 patients) in which primary RRD repair failed were included in this study. Although the anatomic success rates after the second and third RRD repairs were lower than the SOSR (71.7% and 68.1%, respectively), the final anatomic success rates did not significantly differ between eyes that underwent ≥2 RRD repairs (range, 90.6%-100%) (P > 0.05), and final anatomic success was achieved in 95.8% of the eyes. The average VA at both postoperative time intervals and final follow-up decreased with an increased total number of RRD repairs. Eyes that received silicone oil endotamponade during the second RRD repair were 20.3% (P = 0.03) and 38.4% (P = 0.04) less likely to require a third RRD repair compared with eyes that received octafluoropropane and sulfur hexafluoride gases, respectively. Eyes that developed a third RRD due to proliferative vitreoretinopathy (PVR) (n = 43) were 110% more likely to require a fourth RRD repair than eyes that developed a third RRD due to a new tear or failure to reattach (n = 4) (P = 0.04). CONCLUSIONS: In this series, the rates of anatomic success appeared consistent after each surgery when multiple reoperations were required for RRD. The VA decreased with an increased total number of RRD repairs, and the endotamponade choice might have affected the risk of additional reoperations. Proliferative vitreoretinopathy was a significant prognostic factor for RRD recurrence.


Assuntos
Descolamento Retiniano , Vitreorretinopatia Proliferativa , Seguimentos , Humanos , Descolamento Retiniano/diagnóstico , Descolamento Retiniano/etiologia , Descolamento Retiniano/cirurgia , Estudos Retrospectivos , Recurvamento da Esclera/efeitos adversos , Vitrectomia/efeitos adversos , Vitreorretinopatia Proliferativa/cirurgia
3.
Retina ; 40(7): 1331-1338, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31259807

RESUMO

PURPOSE: To evaluate patient-reported visual function after ocriplasmin through the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) in patients with symptomatic vitreomacular adhesion/vitreomacular traction including macular hole. METHODS: This was a prespecified analysis of a secondary endpoint from the OASIS trial. Patients received a single intravitreal injection of ocriplasmin (0.125 mg) or sham and completed the VFQ-25 questionnaire at baseline and at Months 6, 12, and 24. Clinically meaningful (≥5-point) changes from baseline were assessed. RESULTS: Of the 220 patients enrolled, 146 received ocriplasmin and 74 received sham. At Month 24, the percentage of patients with a ≥5-point improvement from baseline in VFQ-25 composite scores was higher with ocriplasmin versus sham (51.4% vs. 30.1%, 95% confidence interval, 8.1-34.5, P = 0.003). The percentage of patients with ≥5-point worsening at Month 24 was lower with ocriplasmin versus sham (9.5% vs. 15.6%, 95% confidence interval: -15.6 to 3.5, P = 0.191). A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status. CONCLUSION: A larger percentage of patients with symptomatic vitreomacular adhesion/vitreomacular traction reported clinically meaningful improvements in self-assessed visual function with ocriplasmin than sham.


Assuntos
Medidas de Resultados Relatados pelo Paciente , Retina/patologia , Perfurações Retinianas/tratamento farmacológico , Tomografia de Coerência Óptica/métodos , Acuidade Visual , Corpo Vítreo/patologia , Idoso , Método Duplo-Cego , Feminino , Fibrinolisina , Humanos , Injeções Intravítreas , Masculino , Fragmentos de Peptídeos , Perfurações Retinianas/diagnóstico , Inquéritos e Questionários
4.
Retina ; 38(2): 364-378, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28198785

RESUMO

PURPOSE: To explore a possible association between full-field electroretinograms with vitreomacular adhesion resolution and best-corrected visual acuity as part of the prospective, randomized, double-masked, sham-controlled Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial studying ocriplasmin. METHODS: The ERG substudy enrolled 62 of 220 OASIS subjects (randomized 2:1) and analyzed full-field electroretinograms and their association with both vitreomacular adhesion resolution and best-corrected visual acuity from baseline through Month 24. Electroretinogram reductions were defined as acute full-field electroretinogram reductions in amplitude of ≥40% from baseline occurring at postinjection Day 7 or Day 28. RESULTS: In the ocriplasmin group, 16/40 (40%) subjects developed ERG reductions, compared to 1/21 (4.8%) in the sham group; 13/16 (81.3%) and 1/1 (100%) resolved by study end, respectively. A total of 11/16 (68.8%) ocriplasmin-treated subjects with ERG reductions achieved vitreomacular adhesion resolution, compared to those without (9/24, 37.5%). The ocriplasmin-treated subjects with ERG reductions also gained more letters on average (11.3 vs. 9.3 letters) from baseline and had a difference of 6.7 letters in mean best-corrected visual acuity by study end compared to those without ERG reductions. CONCLUSION: Ocriplasmin-treated subjects with ERG reductions had a higher rate of vitreomacular adhesion resolution and showed better visual improvement than their counterparts without ERG reductions or sham subjects by study end.


Assuntos
Eletrorretinografia/efeitos dos fármacos , Fibrinolisina/administração & dosagem , Macula Lutea/patologia , Fragmentos de Peptídeos/administração & dosagem , Perfurações Retinianas/tratamento farmacológico , Acuidade Visual , Corpo Vítreo/patologia , Descolamento do Vítreo/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Macula Lutea/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Perfurações Retinianas/complicações , Perfurações Retinianas/fisiopatologia , Fatores de Tempo , Aderências Teciduais/tratamento farmacológico , Aderências Teciduais/etiologia , Aderências Teciduais/fisiopatologia , Resultado do Tratamento , Corpo Vítreo/fisiopatologia , Descolamento do Vítreo/complicações , Descolamento do Vítreo/fisiopatologia
5.
Retina ; 36(7): 1349-56, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26655622

RESUMO

PURPOSE: To determine the rate of postintravitreal injection endophthalmitis and to assess microbiological features and outcomes with and without the use of peri-intravitreal injection topical ophthalmic antibiotics. METHODS: Consecutive series of endophthalmitis cases retrospectively identified after intravitreal injection at a multicenter, retina-only referral practice (Retina Consultants of Houston) from January 1, 2011 to December 31, 2014. Prophylactic peri-intravitreal injection topical antibiotics were routinely used during the initial 12-month period (January 1, 2011-December 31, 2011) and not used in the final 24-month period (January 1, 2013-December 31, 2014). Main outcome measures were incidence of endophthalmitis, microbiology results, treatment strategies, and visual outcomes. RESULTS: Of 90,339 intravitreal injections, 30 cases of endophthalmitis were identified (endophthalmitis rate = 0.033%; 95% confidence interval, 0.021-0.045%; or approximately 1 of 3,011 intravitreal injections). The most common organisms isolated were coagulase-negative staphylococci (n = 10, 33%), followed by Streptococcus mitis (n = 2, 7%). Fourteen cases (47%) were culture negative. Peri-intravitreal injection topical antibiotic prophylaxis did not decrease the rate of endophthalmitis (0.035% [95% CI, 0.007-0.064%] with antibiotic use versus 0.021% [95% CI, 0.008-0.033%] without antibiotic use; P = 0.261). CONCLUSION: The risk of endophthalmitis after intravitreal injection remains low, with coagulase-negative staphylococci and Streptococcus mitis the most common bacterial isolates identified. Prophylactic peri-intravitreal injection topical ophthalmic antibiotic use did not decrease the endophthalmitis rate.


Assuntos
Antibacterianos/administração & dosagem , Antibioticoprofilaxia , Endoftalmite/epidemiologia , Infecções Oculares Bacterianas/epidemiologia , Injeções Intravítreas , Complicações Pós-Operatórias , Administração Tópica , Adulto , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/uso terapêutico , Bactérias/isolamento & purificação , Retinopatia Diabética/tratamento farmacológico , Endoftalmite/microbiologia , Endoftalmite/prevenção & controle , Infecções Oculares Bacterianas/microbiologia , Infecções Oculares Bacterianas/prevenção & controle , Feminino , Humanos , Incidência , Degeneração Macular/tratamento farmacológico , Edema Macular/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Triancinolona Acetonida/uso terapêutico , Corpo Vítreo/microbiologia
6.
Retina ; 35(6): 1151-7, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25741816

RESUMO

PURPOSE: To evaluate visual function in patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction including when associated with macular hole after ocriplasmin treatment, and the association between resolution of the underlying condition and improvement in visual function. METHODS: Six hundred and fifty-two patients from 2 Phase 3 trials received a single intravitreal injection of ocriplasmin 125 µg (n = 464) or placebo (n = 188). Mean and categorical changes from baseline in best-corrected visual acuity and 25-item Visual Function Questionnaire scores were used to evaluate visual function. Subgroups with VMA resolution and full-thickness macular hole closure were compared. RESULTS: Overall, 42% of patients who achieved VMA resolution at Day 28 had a ≥2-line improvement in best-corrected visual acuity at Month 6, and 20% had a ≥3-line improvement. Likewise, 69% of patients with nonsurgical full-thickness macular hole closure at Day 28 had a ≥2-line improvement at Month 6, and 48% had a ≥3-line best-corrected visual acuity improvement. Mean improvements in 25-item Visual Function Questionnaire scores were associated with achieving VMA resolution and nonsurgical full-thickness macular hole closure. CONCLUSION: In patients with symptomatic VMA/vitreomacular traction, VMA resolution and nonsurgical full-thickness macular hole closure were each associated with improvements in visual function. Resolving the underlying anatomical condition in symptomatic VMA/vitreomacular traction will increase the probability of achieving a clinically meaningful improvement in visual function.


Assuntos
Oftalmopatias/tratamento farmacológico , Fibrinolisina/uso terapêutico , Fibrinolíticos/uso terapêutico , Fragmentos de Peptídeos/uso terapêutico , Doenças Retinianas/tratamento farmacológico , Perfurações Retinianas/tratamento farmacológico , Acuidade Visual/fisiologia , Corpo Vítreo/efeitos dos fármacos , Método Duplo-Cego , Oftalmopatias/diagnóstico , Oftalmopatias/fisiopatologia , Fibrinolisina/efeitos adversos , Fibrinolíticos/efeitos adversos , Seguimentos , Humanos , Injeções Intravítreas , Fragmentos de Peptídeos/efeitos adversos , Doenças Retinianas/diagnóstico , Doenças Retinianas/fisiopatologia , Perfurações Retinianas/diagnóstico , Perfurações Retinianas/fisiopatologia , Perfil de Impacto da Doença , Inquéritos e Questionários , Aderências Teciduais/tratamento farmacológico , Corpo Vítreo/patologia
7.
Retina ; 35(4): 687-94, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25621943

RESUMO

PURPOSE: To evaluate retinal sensitivity in patients with diabetic macular edema who received intravitreal aflibercept injection (IAI) or laser. METHODS: A substudy included 46 patients from DA VINCI (a randomized, double-masked Phase 2 study) receiving either laser, 0.5 mg IAI every 4 weeks, 2 mg IAI every 4 weeks, 2 mg IAI every 8 weeks after 3 monthly doses (2q8), or 2 mg IAI as-needed after 3 monthly doses for 52 weeks. Retinal sensitivity was measured in one (central), five (one central and four inner), and eight (four inner and four outer) optical coherence tomography subfields. RESULTS: Mean best-corrected visual acuity improvement in the subgroup at Week 52 was 3.3 letters with laser and ranged from 5.4 to 16.3 letters in the IAI groups. Retinal sensitivity of laser patients at Week 52 was comparable with baseline in the central optical coherence tomography subfield but decreased in the five and eight optical coherence tomography subfields. Compared with laser, retinal sensitivity significantly increased with IAI in the 2q8 and pooled IAI groups in the 5 and 8 optical coherence tomography subfields at Week 52 (P < 0.05). CONCLUSION: Intravitreal aflibercept injection improved best-corrected visual acuity and retinal sensitivity in this subgroup of patients. Laser may cause a deterioration of macular function that is not detectable with best-corrected visual acuity testing.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Retinopatia Diabética/tratamento farmacológico , Edema Macular/tratamento farmacológico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Retina/fisiologia , Campos Visuais/fisiologia , Idoso , Inibidores da Angiogênese/efeitos adversos , Retinopatia Diabética/fisiopatologia , Método Duplo-Cego , Feminino , Humanos , Injeções Intravítreas , Fotocoagulação a Laser , Edema Macular/fisiopatologia , Masculino , Pessoa de Meia-Idade , Receptores de Fatores de Crescimento do Endotélio Vascular/efeitos adversos , Proteínas Recombinantes de Fusão/efeitos adversos , Tomografia de Coerência Óptica , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Acuidade Visual/efeitos dos fármacos , Testes de Campo Visual
8.
Ophthalmology ; 122(1): 117-22, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25240630

RESUMO

PURPOSE: To evaluate the efficacy of a single intravitreal injection of ocriplasmin 125 µg across relevant subpopulations of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT), including when associated with macular hole. DESIGN: Two multicenter, randomized, placebo-controlled, double-masked, 6-month studies. PARTICIPANTS: A total of 652 randomized patients (464 receiving ocriplasmin; 188 receiving placebo). METHODS: A single intravitreal injection of ocriplasmin 125 µg or placebo in the study eye. MAIN OUTCOME MEASURES: Prespecified subgroup analyses were conducted to evaluate the effects on the proportion of patients with nonsurgical resolution of focal VMA at day 28, nonsurgical full-thickness macular hole (FTMH) closure at month 6, and categoric improvement in best-corrected visual acuity (BCVA) at month 6. RESULTS: Resolution of VMA at day 28 was achieved more often in younger patients (<65 years), eyes without epiretinal membrane, eyes with FTMH, phakic eyes, and eyes with a focal VMA ≤ 1500 µm. Eyes with FTMH width ≤ 250 µm were more likely to achieve nonsurgical FTMH closure. Categoric ≥ 2-line and ≥ 3-line improvement in BCVA occurred more often in younger patients (<65 years) and in patients with a lower baseline BCVA (<65 letters). Treatment differences in favor of ocriplasmin were generally observed across each subgroup of subpopulations studied. CONCLUSIONS: Subgroup analyses confirmed the positive effect of ocriplasmin across relevant subpopulations.


Assuntos
Oftalmopatias/tratamento farmacológico , Fibrinolisina/uso terapêutico , Fibrinolíticos/uso terapêutico , Adesões Focais/efeitos dos fármacos , Fragmentos de Peptídeos/uso terapêutico , Doenças Retinianas/tratamento farmacológico , Corpo Vítreo/efeitos dos fármacos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Oftalmopatias/diagnóstico , Feminino , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Doenças Retinianas/diagnóstico , Tomografia de Coerência Óptica , Resultado do Tratamento , Acuidade Visual/fisiologia , Corpo Vítreo/patologia , Adulto Jovem
9.
Pediatr Radiol ; 44(8): 1026-30, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24577685

RESUMO

This feasibility study has shown that improved spatial resolution and reduced radiation dose can be achieved in pediatric CT by narrowing the X-ray photon energy spectrum. This is done by placing a hafnium filter between the X-ray generator and a pediatric abdominal phantom. A CT system manufactured in 1999 that was in the process of being remanufactured was used as the platform for this study. This system had the advantage of easy access to the X-ray generator for modifications to change the X-ray photon energy spectrum; it also had the disadvantage of not employing the latest post-imaging noise reduction iterative reconstruction technology. Because we observed improvements after changing the X-ray photon energy spectrum, we recommend a future study combining this change with an optimized iterative reconstruction noise reduction technique.


Assuntos
Pediatria/métodos , Doses de Radiação , Tomografia Computadorizada por Raios X/instrumentação , Tomografia Computadorizada por Raios X/métodos , Algoritmos , Estudos de Viabilidade , Processamento de Imagem Assistida por Computador/métodos , Imagens de Fantasmas , Raios X
10.
Retin Cases Brief Rep ; 7(4): 304-6, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-25383823

RESUMO

PURPOSE: To report a case of Purtscher-like retinopathy associated with pemphigus vulgaris. METHOD: Case report of a 25-year-old Hispanic male who was referred for sudden and severe reduction of vision from his right eye shortly after an exacerbation of pemphigus vulgaris. RESULTS: Fundus examination of the right eye revealed severe macular edema, nerve fiber layer infarcts, flame-shaped hemorrhages, and venous dilation. Fluorescein angiography and optical coherence tomography findings of flecken, ischemia with subsequent nerve fiber layer atrophy, and capillary leakage were consistent with Purtscher-like retinopathy. The patient was treated with 5 consecutive monthly intravitreal injections of 0.5 mg of ranibizumab. Visual acuity improved with resolution of macular edema, and the patient was started on systemic mycophenolate mofetil. Continued ocular stability was achieved with 11 subsequent intravitreal injections over the following 2 years. CONCLUSION: Purtscher-like retinopathy may have been associated with pemphigus vulgaris through a complement activation process that is previously undescribed. Retinal findings were successfully mitigated with the use of intravitreal anti-vascular endothelial growth factor therapy.

11.
N Engl J Med ; 367(7): 606-15, 2012 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-22894573

RESUMO

BACKGROUND: Vitreomacular adhesion can lead to pathologic traction and macular hole. The standard treatment for severe, symptomatic vitreomacular adhesion is vitrectomy. Ocriplasmin is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface. METHODS: We conducted two multicenter, randomized, double-blind, phase 3 clinical trials to compare a single intravitreal injection of ocriplasmin (125 µg) with a placebo injection in patients with symptomatic vitreomacular adhesion. The primary end point was resolution of vitreomacular adhesion at day 28. Secondary end points were total posterior vitreous detachment and nonsurgical closure of a macular hole at 28 days, avoidance of vitrectomy, and change in best-corrected visual acuity. RESULTS: Overall, 652 eyes were treated: 464 with ocriplasmin and 188 with placebo. Vitreomacular adhesion resolved in 26.5% of ocriplasmin-injected eyes and in 10.1% of placebo-injected eyes (P<0.001). Total posterior vitreous detachment was more prevalent among the eyes treated with ocriplasmin than among those injected with placebo (13.4% vs. 3.7%, P<0.001). Nonsurgical closure of macular holes was achieved in 40.6% of ocriplasmin-injected eyes, as compared with 10.6% of placebo-injected eyes (P<0.001). The best-corrected visual acuity was more likely to improve by a gain of at least three lines on the eye chart with ocriplasmin than with placebo. Ocular adverse events (e.g., vitreous floaters, photopsia, or injection-related eye pain--all self-reported--or conjunctival hemorrhage) occurred in 68.4% of ocriplasmin-injected eyes and in 53.5% of placebo-injected eyes (P<0.001), and the incidence of serious ocular adverse events was similar in the two groups (P=0.26). CONCLUSIONS: Intravitreal injection of the vitreolytic agent ocriplasmin resolved vitreomacular traction and closed macular holes in significantly more patients than did injection of placebo and was associated with a higher incidence of ocular adverse events, which were mainly transient. (Funded by ThromboGenics; ClinicalTrials.gov numbers, NCT00781859 and NCT00798317.).


Assuntos
Oftalmopatias/tratamento farmacológico , Fibrinolisina/uso terapêutico , Fragmentos de Peptídeos/uso terapêutico , Perfurações Retinianas/tratamento farmacológico , Corpo Vítreo/patologia , Adulto , Método Duplo-Cego , Humanos , Injeções Intravítreas , Retina/patologia , Acuidade Visual
12.
Ophthalmology ; 118(6): 1089-97, 2011 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21640257

RESUMO

OBJECTIVE: To evaluate the biologic effects and safety of vascular endothelial growth factor (VEGF) Trap-Eye during a 12-week fixed-dosing period in patients with neovascular (wet) age-related macular degeneration (AMD). DESIGN: Multicenter, prospective, randomized, double-masked clinical trial with initial 12-week fixed dosing period. Data were analyzed to week 16. PARTICIPANTS: We included 159 patients with subfoveal choroidal neovascularization secondary to wet AMD. METHODS: Patients were randomized 1:1:1:1:1 to VEGF Trap-Eye during the fixed-dosing phase (day 1 to week 12): 0.5 or 2 mg every 4 weeks (0.5 mg q4wk, 2 mg q4wk) on day 1 and at weeks 4, 8, and 12; or 0.5, 2, or 4 mg every 12 weeks (0.5 mg q12wk, 2 mg q12wk, or 4 mg q12wk) on day 1 and at week 12. MAIN OUTCOME MEASURES: The primary endpoint was change from baseline in central retinal/lesion thickness (CR/LT) at week 12; secondary outcomes included change in best-corrected visual acuity (BCVA), proportion of patients with a gain of ≥ 15 letters, proportion of patients with a loss of >15 letters, and safety. RESULTS: At week 12, treatment with VEGF Trap-Eye resulted in a significant mean decrease in CR/LT of 119 µm from baseline in all groups combined (P<0.0001). The reduction in CR/LT with the 2 mg q4wk and 0.5mg q4wk regimens was significantly greater than each of the quarterly dosing regimens. The BCVA increased significantly by a mean of 5.7 letters at 12 weeks in the combined group (P<0.0001), with the greatest mean gain of >8 letters in the monthly dosing groups. At 8 weeks, BCVA improvements were similar with 2 mg q4wk and 2 mg q12wk dosing. After the last required dose at week 12, CR/LT and visual acuity were maintained or further improved at week 16 in all treatment groups. Ocular adverse events were mild and consistent with safety profiles reported for other intraocular anti-VEGF treatments. CONCLUSIONS: Repeated monthly intravitreal dosing of VEGF Trap-Eye over 12 weeks demonstrated significant reductions in retinal thickness and improvements in visual acuity, and was well-tolerated in patients with neovascular AMD. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.


Assuntos
Neovascularização de Coroide/prevenção & controle , Fóvea Central/patologia , Fator A de Crescimento do Endotélio Vascular/administração & dosagem , Degeneração Macular Exsudativa/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Neovascularização de Coroide/diagnóstico , Neovascularização de Coroide/etiologia , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Seguimentos , Fóvea Central/efeitos dos fármacos , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/uso terapêutico , Acuidade Visual , Degeneração Macular Exsudativa/complicações , Degeneração Macular Exsudativa/diagnóstico
13.
Clin Ophthalmol ; 4: 1249-52, 2010 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-21151329

RESUMO

PURPOSE: The purpose of this study is to determine the efficacy of combining topical nepafenac with monthly intravitreal injections of ranibizumab or bevacizumab in the treatment of recalcitrant exudative macular degeneration. METHODS: This was a retrospective, consecutive case series of patients with exudative macular degeneration requiring maintenance therapy of antivascular endothelial growth factor ( anti-VEGF) injections at least every 6 weeks, who were started on topical nepafenac. Despite frequent anti-VEGF dosing, all patients included in the study had persistence of any combination of the following: intraretinal cysts, subretinal fluid, and/or pigment epithelial detachment. Patients underwent pinhole visual acuity, clinical exam, and optical coherence tomography (OCT) at baseline and every follow-up visit. Response to therapy was graded by reviewing quantitative and qualitative OCT data, and statistical analysis was done with paired Student's t-test. RESULTS: Twenty-five patients (average age 77; 14 male and 11 female) were reviewed; the mean number of previous injections was 17.4 (range 3-31). Baseline mean visual acuity was 20/55, and final mean visual acuity after 3 months of treatment was 20/51 (P = 0.13). Monthly mean central foveal thickness measurements were 248, 250, 257, and 247 µm (P = 0.53) at baseline, 1, 2, and 3 months, respectively. By the end of the 3-month time point, qualitative OCT findings on 13 patients treated with nepafenac were classified as stable, 10 as better, and 2 as worse. CONCLUSIONS: There was no significant change in visual acuity or quantitative OCT measurements, but there appeared to be a mild trend toward improved anatomy and qualitative OCT findings when topical nepafenac was added to monthly anti-VEGF injections in patients with persistent intraretinal cysts, subretinal fluid, and/or pigment epithelial detachment. Further prospective studies with longer follow-up may be warranted.

14.
Clin Ophthalmol ; 4: 1151-8, 2010 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-21060664

RESUMO

PURPOSE: While the long-term incidence of hydroxychloroquine (HCQ) retinopathy is low, there remains no definitive clinical screening test to recognize HCQ toxicity before ophthalmoscopic fundus changes or visual symptoms. Patients receiving HCQ were evaluated with spectral domain optical coherence tomography (SD OCT) to assess the feasibility of identifying HCQ retinopathy at an early stage. METHODS: Twenty-five patients referred for the evaluation of hydroxychloroquine toxicity underwent a comprehensive ocular examination, Humphrey visual field (HVF) perimetry, time domain OCT, and SD OCT. Some patients with screening abnormalities also underwent further diagnostic testing at the discretion of the treating providers. RESULTS: Five patients were found to have SD OCT findings corresponding to HCQ toxicity and retinal damage as seen by clinical exam and/or HVF perimetry. Two patients with advanced toxicity were found to have significant outer retina disruption in the macula on SD OCT. Three patients with early HCQ toxicity and HVF 10-2 perifoveal defects were found to have loss of the perifoveal photoreceptor inner segment/outer segment (IS/OS) junction with intact outer retina directly under the fovea, creating the "flying saucer" sign. While two of these three patients had early ophthalmoscopic fundus changes, one had none. CONCLUSION: Outer retinal abnormalities including perifoveal photoreceptor IS/OS junction disruption can be identified by SD OCT in early HCQ toxicity, sometimes even before ophthalmoscopic fundus changes are apparent. SD OCT may have a potential complementary role in screening for HCQ retinopathy due to its quick acquisition and because it is more objective than automated perimetry.

15.
Clin Ophthalmol ; 4: 1073-9, 2010 Oct 05.
Artigo em Inglês | MEDLINE | ID: mdl-20957143

RESUMO

PURPOSE: Combination verteporfin photodynamic therapy (vPDT) and antivascular endothelial growth factor (anti-VEGF) therapy may decrease the need for injections while maintaining visual acuity in exudative age-related macular degeneration. This pilot study was designed to determine the threshold fluence dose of vPDT (the dose required to demonstrate an effect on choroidal perfusion) combined with ranibizumab. METHODS: Seven patients were randomized to sham vPDT (two patients), 20% fluence vPDT (two patients), or 40% fluence vPDT (three patients) in combination with three-monthly intravitreal 0.5 mg ranibizumab injections. Intravitreal ranibizumab was reinjected if disease activity was seen on fluorescein angiography, optical coherence tomography, or clinical examination. Indocyanine green-determined choroidal hypoperfusion was graded in a masked fashion. RESULTS: Patients with 20% vPDT had mild hypoperfusion defects at seven days that resolved by week 4 (threshold dose); patients with 40% fluence vPDT had marked hypoperfusion at seven days that persisted as long as 12 months. Recruitment was stopped after limited efficacy was observed. One patient with 20% fluence vPDT lost 19 letters at one year; no other patient lost or gained >10 letters. Central retinal thickness decreased in six of seven patients, but ranibizumab injections did not decrease. CONCLUSION: This pilot study shows that the threshold fluence dose of vPDT (when combined with ranibizumab) is approximately 20% standard fluence, and that mild and transient choroidal hypoperfusion can occur. Forty percent fluence vPDT causes a more prolonged and striking hypoperfusion. Despite hypoperfusion, no decrease in visual acuity or injections required was noted, suggesting that even higher fluence levels of vPDT may be necessary to decrease the number of anti-VEGF injections.

16.
Ophthalmology ; 117(4): 791-7, 2010 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-20138368

RESUMO

PURPOSE: To evaluate the safety and efficacy of a preoperative intravitreous injection of microplasmin in patients scheduled for vitreous surgery. DESIGN: Phase 2, multicenter, placebo-controlled, double-masked, parallel-group, dose-ranging clinical trial. PARTICIPANTS: One hundred twenty-five patients scheduled for pars plana vitrectomy (PPV), primarily for treatment of either vitreomacular traction or macular hole. INTERVENTION: A single intravitreous injection of either microplasmin at 1 of 3 doses (25 microg, 75 microg, or 125 microg in 100 microl) or placebo injection administered 7 days before PPV. MAIN OUTCOME MEASURES: Presence or absence of posterior vitreous detachment (PVD) at the time of PPV, progression of PVD, and resolution of vitreomacular interface abnormality precluding the need for PPV. RESULTS: Rates of total PVD at the time of surgery were 10%, 14%, 18%, and 31% in the placebo group (n = 30), 25-microg (n = 29), 75-microg (n = 33), and 125-microg microplasmin groups (n = 32), respectively. The secondary end point resolution of vitreomacular interface abnormality precluding the need for vitrectomy at the 35-day time point was observed at rates of 3%, 10%, 15%, and 31% in the placebo, and the 25-microg, the 75-microg, and the 125-microg microplasmin groups, respectively. At the 180-day time point, the equivalent rates were 3%, 7%, 15%, and 28%, respectively. CONCLUSIONS: Microplasmin injection at a dose of 125 microg led to a greater likelihood of induction and progression of PVD than placebo injection. Patients receiving microplasmin were significantly more likely not to require vitrectomy surgery. More definitive evaluation in phase 3 clinical trials therefore is warranted. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.


Assuntos
Fibrinolisina/administração & dosagem , Fibrinolíticos/administração & dosagem , Fragmentos de Peptídeos/administração & dosagem , Vitrectomia , Descolamento do Vítreo/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Quimioterapia Adjuvante , Método Duplo-Cego , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Perfurações Retinianas/cirurgia , Tomografia de Coerência Óptica , Acuidade Visual/fisiologia , Corpo Vítreo , Adulto Jovem
17.
Ophthalmic Surg Lasers Imaging ; 40(3): 325-8, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19485303

RESUMO

The authors report four cases where spectral domain optical coherence tomography (SD-OCT) imaged pathology not captured by time domain optical coherence tomography (TD-OCT). These cases include one of angioid streaks, two of juxtafoveal telangiectasia, and one of age-related macular degeneration. In each case, the improved images provided by SD-OCT changed either the management of the patient or the counseling of their disease process.


Assuntos
Estrias Angioides/diagnóstico , Degeneração Macular/diagnóstico , Doenças Retinianas/diagnóstico , Telangiectasia/diagnóstico , Tomografia de Coerência Óptica/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Análise de Fourier , Fóvea Central , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Fatores de Tempo
19.
Ophthalmic Surg Lasers Imaging ; 38(1): 59-60, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17278538

RESUMO

A 65-year-old man presented after macular hole surgery with trypan blue-assisted internal limiting membrane peeling in his left eye. Although the patient had no visual complaints in the left eye, on clinical examination an eccentric full-thickness macular hole was noted just inside the superior vascular arcade and documented by optical coherence tomography. The patient was observed and continued to remain asymptomatic.


Assuntos
Perfurações Retinianas/etiologia , Vitrectomia/efeitos adversos , Idoso , Seguimentos , Humanos , Masculino , Complicações Pós-Operatórias , Perfurações Retinianas/patologia , Tomografia de Coerência Óptica , Acuidade Visual , Vitrectomia/métodos
20.
Am J Ophthalmol ; 143(3): 504-5, 2007 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-17317395

RESUMO

PURPOSE: To report two cases of retinal pigment epithelium (RPE) tears following intravitreous ranibizumab injection for age-related macular degeneration (AMD)-associated serous pigment epithelium detachment (PED). DESIGN: Noncomparative case series. METHODS: The charts of two patients who received intravitreous ranibizumab for AMD-associated PED and developed RPE tears were reviewed. Fundus photography, fluorescein angiography and optical coherence tomography performed prior to injection and upon follow-up confirmed the diagnosis. RESULTS: Two patients with serous PED and occult choroidal neovascularization associated with AMD developed RPE tears within four weeks of injection with ranibizumab. CONCLUSIONS: RPE tears may complicate ranibizumab intravitreous injection for the treatment of AMD-associated PEDs. Further studies need be undertaken to determine whether this complication may also occur when treating choroidal neovascular membranes not associated with PED and whether certain angiographic subtypes are more susceptible to this complication.


Assuntos
Inibidores da Angiogênese/efeitos adversos , Anticorpos Monoclonais/efeitos adversos , Degeneração Macular/tratamento farmacológico , Epitélio Pigmentado Ocular/efeitos dos fármacos , Perfurações Retinianas/induzido quimicamente , Idoso , Anticorpos Monoclonais Humanizados , Neovascularização de Coroide/tratamento farmacológico , Angiofluoresceinografia , Humanos , Injeções , Masculino , Epitélio Pigmentado Ocular/patologia , Ranibizumab , Perfurações Retinianas/diagnóstico , Tomografia de Coerência Óptica , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Corpo Vítreo
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