THE EFFECT OF ELECTIVE CATARACT EXTRACTION BY PHACOEMULSIFICATION IN EYES WITH VITREOMACULAR TRACTION SYNDROME.

PURPOSE: To evaluate the effect of cataract extraction (CE) by phacoemulsification on the vitreomacular interface (VMI) of eyes with preexisting vitreomacular traction (VMT). METHODS: Retrospective, observational case series. Patients with VMT who elected to proceed with CE, before any vitreoretinal intervention, were studied. Eyes with at least a 12-month follow-up period were included. The status of the vitreomacular adhesion at different time points was assessed using spectral-domain optical coherence tomography. The best-corrected visual acuity was recorded at different time points. Other macular and systemic comorbidities were documented. RESULTS: Fifteen eyes from 15 phakic patients with symptomatic VMT were included. Six of them were male subjects. Seven patients had diabetes mellitus and two of them also had nonproliferative diabetic retinopathy. The preoperative macular comorbidities included macular hole in six eyes (Stage 1 in 3 eyes and Stage 2 or 3 in another 3 eyes), epiretinal membrane in five eyes, and cystoid macular edema in four eyes. After uncomplicated CE, the VMT was released in 5 eyes, whereas in 10 eyes, CE did not significantly change the status of the vitreomacular adhesion. Three of 3 eyes with preexisting full-thickness macular hole (Stage 2 or 3 macular hole) were found to have Stage 4 macular hole shortly after CE. In seven of seven patients with diabetes mellitus, the status of the vitreomacular interface did not change after CE. Eventually, 7 of 15 patients underwent additional pars plana vitrectomy. Compared with the baseline vision, and vision before other interventions, the visual acuity after CE improved in 5 patients, remained unchanged in 7 patients, and decreased in the 3 patients with Stage 2 or 3 macular hole. The mean preoperative and early postoperative visual acuity was 20/59 and 20/68, respectively (P > 0.05). CONCLUSION: The effect of CE in phakic eyes with known VMT varies significantly. In the current case series, every eye with VMT and Stage 2 or 3 macular hole ended up with Stage 4 macular hole, although the VMT did not change significantly in the eyes of diabetic patients. Studies with larger sample size are needed to further elucidate the impact of elective CE on VMT.

CLINICAL FINDINGS IN TRIAMCINOLONE-ASSOCIATED MACULOPATHY.

PURPOSE: To describe a crystalline retinopathy observed in patients greater than 1 year after intravitreal injection of triamcinolone acetonide (IVTA). METHODS: A retrospective, interventional, noncomparative, single-center case series of patients who received IVTA and developed subsequent crystalline retinopathy lasting greater than 1 year after injection. RESULTS: Eighteen eyes of 16 patients in which preretinal crystals were observed >1 year after IVTA were included in the study, with a mean follow-up (range) of 5.8 years (1.1-9.2) after IVTA. The crystals were refractile, not visible on fluorescein nor indocyanine green angiography, exhibited slow dissolution and movement, and were occasionally distributed in a circular fashion. Optical coherence tomography confirmed the preretinal and/or subhyaloid location of crystals. CONCLUSION: Macular crystals can persist for years after IVTA. The crystals localize to the preretinal or subhyaloid space, are angiographically silent, can exhibit slow dissolution and movement, may be distributed in a circular fashion reflecting the bursa premacularis, and appear nonpathologic.

INTRAVITREAL OCRIPLASMIN IN CLINICAL PRACTICE: Predictors of Success, Visual Outcomes, and Complications.

PURPOSE: To investigate predictors of success, visual outcomes, and complications of intravitreal ocriplasmin for the treatment of symptomatic vitreomacular adhesion in a clinical care setting. METHODS: Retrospective chart review of 49 consecutive eyes of 47 patients who received intravitreal ocriplasmin. Spectral domain optical coherence tomography scans were examined for vitreomacular traction (VMT) release, full-thickness macular hole (FTMH) closure, and other changes in retinal anatomy. RESULTS: Pharmacologic VMT release occurred in 41% of eyes; positive predictors included age ≤75 years (P = 0.001), phakic status (P = 0.016), VMT width ≤750 µm (P = 0.001), and absence of retinal comorbidities (P = 0.035). Pharmacologic FTMH closure occurred in 25% of cases; positive predictors included successful VMT release (P = 0.042), better preinjection best-corrected visual acuity (P = 0.036), and smaller FTMH aperture width (P = 0.033). Eyes that achieved VMT release and did not undergo surgery attained significant improvement in best-corrected visual acuity (P = 0.015). Complications included subfoveal lucency (33%), ellipsoid zone disruption (33%), and FTMH base enlargement (75%). Only FTMH base enlargement resulted in worse visual outcomes (P = 0.024). Subgroup analysis of 14 eyes with ideal characteristics (all positive predictors listed above) yielded a 93% VMT release rate. CONCLUSION: Proper case selection may facilitate successful pharmacologic vitreolysis with ocriplasmin, improve visual outcomes, and minimize potential complications.

Frequency and characteristics of intraocular inflammation after aflibercept injection.

PURPOSE: To report the frequency and characteristics of intraocular inflammation after intravitreal aflibercept injection. METHODS: A single-center retrospective study was performed in patients who received intravitreal aflibercept from November 2011 through June 2013. RESULTS: There were 28 cases of intraocular inflammation after a total of 5,905 aflibercept injections among 1,660 patients. The mean baseline acuity was 20/57, which decreased to 20/179 at diagnosis (P < 0.0001) but recovered to 20/59 at Month 1, 20/57 at Month 3, and 20/52 at Month 6 (P = not significant). Vitreous culture and injection of antibiotics were performed in eight cases, and all were culture negative; the remainder received only topical corticosteroids. CONCLUSION: The frequency of inflammation after aflibercept was 0.47% per injection. Visual acuity and inflammation returned to baseline within 1 month in most cases with topical corticosteroid treatment.

Two or more dexamethasone intravitreal implants in treatment-naïve patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study.

BACKGROUND: Dexamethasone intravitreal implant (DEX implant) is a biodegradable, sustained-release implant that releases dexamethasone for up to 6 months. We evaluated the efficacy and safety of DEX implant in the treatment of macular edema secondary to retinal vein occlusion (RVO) in treatment-naïve patients. METHODS: A multicenter, retrospective, open-label chart review study investigated the efficacy and safety of DEX implant treatment in 289 patients with macular edema secondary to branch or central RVO (BRVO, CRVO) who received ≥2 treatments with DEX implant in the study eye. Concomitant adjunctive RVO treatments were permitted. Data collected from the time of the first implant (baseline) to 3-6 months after the last implant included best-corrected visual acuity (BCVA) and central retinal thickness measured with optical coherence tomography. In this subgroup analysis, we evaluated outcomes in patients who had received no previous treatment for RVO complications. RESULTS: Thirty-nine patients were treatment-naïve at the time of their first DEX implant (18 BRVO, 21 CRVO). Before the initial DEX implant, the mean duration of macular edema in treatment-naïve patients was 4.9 months, mean central retinal thickness was 550 µm, and mean Early Treatment Diabetic Retinopathy Study BCVA was 8.5 lines (20/125 Snellen). Treatment-naïve patients received a mean of 2.9 implants, either as monotherapy (n = 12) or with adjunctive RVO treatments (n = 27). The mean interval between implants was 177 days. After the first through sixth implants, mean changes from baseline BCVA ranged from +3.0 - +8.0 lines, and mean decreases from baseline central retinal thickness ranged from 241-459 µm. BCVA improved in both BRVO and CRVO and in both phakic and pseudophakic eyes. Overall, 83.8 % of treatment-naïve patients gained ≥2 lines in BCVA, 70.3 % gained ≥3 lines in BCVA, and 56.4 % achieved central retinal thickness ≤250 µm. The most common adverse event was increased intraocular pressure. Fifteen treatment-naïve patients had intraocular pressure ≥25 mm Hg; none required laser or incisional glaucoma surgery. CONCLUSION: Treatment with 2 or more DEX implants had a favorable safety profile and improved visual acuity and anatomic outcomes when used, either alone or with adjunctive RVO therapy, as initial treatment for RVO-associated macular edema. TRIAL REGISTRATION: ClinicalTrials.gov NCT01411696 , registered on August 5, 2011.

Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study.

BACKGROUND: Dexamethasone intravitreal implant (DEX implant) is a sustained-release biodegradable implant approved for treatment of macular edema associated with retinal vein occlusion (RVO). The safety and efficacy of treatment of RVO-associated macular edema with sequential DEX implants in clinical practice was evaluated in patients who received DEX implant as monotherapy compared with patients who received DEX implant in combination with other RVO treatments. METHODS: A multicenter, retrospective, open-label chart review study (one study eye/patient) evaluated use of DEX implant and outcomes in 289 patients with branch or central RVO who received at least 2 DEX implant treatments in the study eye. Data were collected from the time of the first implant (baseline) to 3-6 months after the last implant. Subgroup analysis evaluated outcomes in patients receiving only DEX implant during the study versus patients receiving DEX implant plus adjunctive RVO treatments. Endpoints included best-corrected visual acuity (BCVA) and central retinal thickness (CRT) change from baseline. RESULTS: DEX implant was used as monotherapy in 84 (29.1%) patients and in combination with other therapy in 205 (70.9%) patients. Mean number of DEX implant treatments received was 3.1 in the monotherapy group and 3.3 in the combination therapy group (P = 0.344). Mean time between implants was longer in the combination therapy group (177 vs. 151 days, P < 0.001). Mean change from baseline BCVA after the first through sixth DEX implants ranged from +0.6 to +3.4 lines in the monotherapy group and +1.3 to +2.8 lines in the combination therapy group. Mean decrease from baseline CRT ranged from 165 to 230 µm in the monotherapy group and 136 to 175 µm in the combination therapy group. Increased intraocular pressure was more common in the combination therapy group. CONCLUSIONS: Treatment of RVO-associated macular edema with at least 2 sequential DEX implants was safe and effective both when used alone and when combined with other RVO treatments. Improvements in BCVA and CRT were generally similar in the monotherapy and combined therapy groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT01411696 .

Efficacy and safety of two or more dexamethasone intravitreal implant injections for treatment of macular edema related to retinal vein occlusion (Shasta study).

PURPOSE: To evaluate the efficacy, safety, and reinjection interval of dexamethasone intravitreal implant (DEX implant) in branch retinal vein occlusion and central retinal vein occlusion patients receiving ≥ 2 DEX implant treatments. METHODS: Multicenter (26-site), retrospective chart review study. Data were collected from baseline (at first DEX implant) through 3 months to 6 months after last DEX implant. RESULTS: Patients (n = 289) received 2 to 9 (mean, 3.2) DEX implants as monotherapy (29.1% of patients) or with adjunctive treatments/procedures. Mean duration of macular edema before first DEX implant was 18.4 months. Mean reinjection interval was 5.6 months. Mean peak change in best-corrected visual acuity from baseline through 4 weeks to 20 weeks after final DEX implant was +1.0 line (P < 0.001). Best-corrected visual acuity and central retinal thickness improved significantly from baseline after each of the first 6 DEX implant injections (P ≤ 0.037); 59.7% of branch retinal vein occlusion and 66.7% of central retinal vein occlusion patients achieved ≥ 2-line best-corrected visual acuity improvement. Intraocular pressure increase (≥ 10 mmHg) occurred in 32.6% of patients; 29.1% used intraocular pressure-lowering medication to treat increases associated with DEX implant. Only 1.7% of patients required incisional glaucoma surgery. CONCLUSION: Retinal vein occlusion patients treated with multiple DEX implant injections, either alone or combined with other therapies, had improved central retinal thickness and visual acuity with each subsequent injection. No new safety concerns developed with multiple implants.

The 0.19-mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema: Intraocular Pressure-Related Effects over 36 Months.

PURPOSE: To evaluate effects of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN) on intraocular pressure (IOP) in patients with diabetic macular edema (DME). DESIGN: Secondary analysis of a 36-month, phase IV, nonrandomized, open-label, observational study. PARTICIPANTS: The study included 202 eyes from 159 patients who received the 0.19-mg FAc implant after a successful prior steroid challenge per the United States label indication. METHODS: Study eyes were assessed for IOP values, incidence of IOP elevations, and best-corrected visual acuity (BCVA) for up to 36 months post-FAc implant. RESULTS: Mean IOP was stable over 36 months post-FAc; IOP change from baseline peaked at 2.12 mmHg at 9 months, then declined to baseline levels. At 36 months, eyes had a 32.5% cumulative probability of an IOP event > 25 mmHg and a 15.6% probability of an IOP event > 30 mmHg (Kaplan-Meier). The probability of requiring IOP-lowering medication at any time by month 36 was 38.3%. A total of 78% of eyes did not have IOP elevations > 25 mmHg if similar values were seen with the previous steroid challenge. Although 7.4% of eyes had an IOP > 30 mmHg during a scheduled study visit, most exceeded this threshold only once (60%). Regardless of IOP status, mean BCVA remained stable. CONCLUSIONS: Over 36 months, the 0.19-mg FAc implant was associated with relatively stable IOPs in patients with DME, and there was no significant impact of IOP elevations identified regarding their effects on long-term visual outcomes. The probability that a prior corticosteroid challenge will not predict an IOP elevation > 25 mmHg over 36 months post-FAc is 22%; therefore, routine IOP monitoring should be scheduled. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Incidence of choroidal neovascularization in the fellow eye in the comparison of age-related macular degeneration treatments trials.

OBJECTIVE: To assess the influence of drug; dosing regimen; and traditional, nontraditional, and genetic risk factors on the incidence of choroidal neovascularization (CNV) in the fellow eye of patients treated for CNV with ranibizumab or bevacizumab. DESIGN: Cohort study of patients enrolled in a multicenter, randomized clinical trial. PARTICIPANTS: Patients with no CNV in the fellow eye at the time of enrollment in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). METHODS: Eligibility criteria for the clinical trial required that study eyes have evidence on fluorescein angiography and optical coherence tomography of CNV secondary to age-related macular degeneration (AMD) and visual acuity between 20/25 and 20/320. Treatment for the study eye was assigned randomly to either ranibizumab or bevacizumab and to 3 different regimens for dosing over a 2-year period. The genotypes for 4 single nucleotide polymorphisms (SNPs) associated with risk of AMD were determined. Only patients without CNV in the fellow eye at baseline were considered at risk. The CATT ophthalmologists examined patients every 4 weeks through 2 years and recorded treatment for CNV in the fellow eye. MAIN OUTCOME MEASURES: Development of CNV in the fellow eye. RESULTS: Among 1185 CATT participants, 727 (61%) had no CNV in the fellow eye at enrollment. At 2 years, CNV had developed in 75 (20.6%) of 365 patients treated with ranibizumab and in 60 (16.6%) of 362 patients treated with bevacizumab (absolute difference, 4.0%; 95% confidence interval [CI], -1.7% to 9.6%; P = 0.17). The risk ratio for pro re nata dosing relative to monthly dosing was 1.1 (95% CI, 0.8-1.6). Greater elevation of the retinal pigment epithelium and fluid in the foveal center of the study eye were associated with increased incidence of CNV in the fellow eye. Incidence was not associated with genotype on rs1061170 (CFH), rs10490924 (ARMS2), rs11200638 (HTRA1), and rs2230199 (C3; P>0.35). CONCLUSIONS: Through 2 years, there was no statistically significant difference between ranibizumab and bevacizumab in incidence of CNV in the fellow eye. Genotype on 4 SNPs previously found to be associated with AMD did not affect the risk of CNV in the fellow eye among CATT patients. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Reduced Incidence of Intravitreal Injection-Related Endophthalmitis With Prefilled Syringes.

Purpose: To evaluate the incidence and clinical characteristics of intravitreal injection-related endophthalmitis cases with antivascular endothelial growth factor (anti-VEGF) medications manufactured as prefilled syringes or non-prefilled preparations. Methods: This retrospective chart review comprised eyes that received intravitreal anti-VEGF at a single-specialty retina practice from January 1, 2014, to December 31, 2019. Eyes diagnosed with injection-related endophthalmitis were identified. Demographic and clinical data were abstracted from medical records, including the type of anti-VEGF agent, baseline and follow-up corrected visual acuity (VA), and microbiologic findings. Results: The review identified 88 cases of intravitreal anti-VEGF injection-related endophthalmitis and 325 990 total injections. Total injections included 32 045 (9.8%) bevacizumab (BEV), 93 073 (28.6%) ranibizumab (RAN), 122 947 (37.7%) aflibercept (AFL), and 77 925 (23.9%) ranibizumab prefilled syringe (RANPFS). Ten of the endophthalmitis cases were related to BEV, 21 to RAN, 45 to AFL, and 12 to RANPFS. The endophthalmitis rate was lowest for RANPFS (0.0154%) (BEV, 0.0312%; RAN, 0.0226%; AFL, 0.0366%) (P = .030). Thirty-four (41.5%) of 82 samples were culture positive. RANPFS had a significantly lower rate of culture-proven postinjection endophthalmitis than the other agents (P = .003). The mean VA for endophthalmitis cases related to RANPFS vs non-prefilled agents was similar at presentation (Snellen 20/2092 vs 20/2327) and at the 3-month follow-up (Snellen 20/201 vs 20/272) (both P > .05). Conclusions: Anti-VEGF medications in prefilled syringes may reduce the risk for medication contamination during injection preparation. RANPFS was associated with a lower rate of injection-related endophthalmitis than non-prefilled anti-VEGF medications.

Ganglion Cell Layer Thickness Change in Neovascular Age-Related Macular Degeneration Treated With Anti-VEGF Injections.

Purpose: This work assesses bilateral ganglion cell layer-inner plexiform layer (GCL-IPL) thickness changes in patients with unilateral neovascular age-related macular degeneration (nAMD) treated with antivascular endothelial growth factor (anti-VEGF). Methods: In this single-center, retrospective, cohort study, the medical records of patients with unilateral nAMD treated with anti-VEGF were reviewed. The treated group included eyes with newly diagnosed nAMD that subsequently underwent treatment with intravitreal anti-VEGF injections. The control group was the fellow eye with dry AMD. Eyes receiving at least 10 intravitreal injections were included. Measurement of GCL-IPL thickness was performed at different time points using spectral domain-optical coherence tomography. Results: A total of 216 eyes of 108 patients met the inclusion criteria. The mean age ± SD was 80.1 ± 10.7 years. Eyes in the treated group underwent a mean ± SD of 20.2 ± 7.2 injections in 21.3 ± 6.8 months. At baseline, average mean ± SD of GCL-IPL thickness was 73.71 ± 8.81 µm and 73.84 ± 8.26 µm in the treated and fellow eye, respectively (P = .795). After 10 injections the average thickness was 65.41 ± 14.08 µm and 68.77 ± 13.24 µm in the treated and fellow eye, respectively (P = .007). The absolute decrease in thickness was significantly greater in the treated eye than the fellow eye (mean ± SD, 8.31 ± 11.19 µm vs 5.07 ± 10.83 µm, respectively; P = .002). Conclusions: GCL-IPL thickness decreased significantly in the treated group more than in the control group after 10 anti-VEGF injections. The mechanism and clinical significance of this observation warrants further study.

The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing.

OBJECTIVE: To evaluate anatomic outcomes and vision, injection frequency, and safety during the as-needed (PRN) treatment phase of a study evaluating a 12-week fixed dosing period followed by PRN dosing to week 52 with vascular endothelial growth factor (VEGF) Trap-Eye for neovascular (wet) age-related macular degeneration (AMD). DESIGN: Multicenter, randomized, double-masked trial. PARTICIPANTS: We included 159 patients with subfoveal choroidal neovascularization (CNV) secondary to wet AMD. METHODS: Patients were randomly assigned to 1 of 5 intravitreal VEGF Trap-Eye treatment groups: 0.5 mg or 2 mg every 4 weeks or 0.5, 2, or 4 mg every 12 weeks during the fixed-dosing period (weeks 1-12). From weeks 16 to 52, patients were evaluated monthly and were retreated PRN with their assigned dose (0.5, 2, or 4 mg). MAIN OUTCOME MEASURES: Change in central retinal/lesion thickness (CR/LT), change in total lesion and CNV size, mean change in best-corrected visual acuity (BCVA), proportion of patients with 15-letter loss or gain, time to first PRN injection, reinjection frequency, and safety at week 52. RESULTS: The decrease in CR/LT at week 12 versus baseline remained significant at weeks 12 to 52 (-130 µm from baseline at week 52) and CNV size regressed from baseline by 2.21 mm(2) at 48 weeks. After achieving a significant improvement in BCVA during the 12-week, fixed-dosing phase for all groups combined, PRN dosing for 40 weeks maintained improvements in BCVA to 52 weeks (5.3-letter gain; P<0.0001). The most robust improvements and consistent maintenance of visual acuity generally occurred in patients initially dosed with 2 mg every 4 weeks for 12 weeks, demonstrating a gain of 9 letters at 52 weeks. Overall, a mean of 2 injections was administered after the 12-week fixed-dosing phase, and the mean time to first reinjection was 129 days; 19% of patients received no injections and 45% received 1 or 2 injections. Treatment with VEGF Trap-Eye was generally safe and well tolerated, with few ocular or systemic adverse events. CONCLUSIONS: PRN dosing with VEGF Trap-Eye at weeks 16-52 maintained the significant anatomic and vision improvements established during the 12-week fixed-dosing phase with a low frequency of reinjections. Repeated dosing with VEGF Trap-Eye was well tolerated over 52 weeks of treatment. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Publication rates of registered clinical trials in macular degeneration.

PURPOSE: The purpose of this study was to evaluate the rate of publication of registered clinical trials concerning age-related macular degeneration (AMD). METHODS: The National Institutes of Health's ClinicalTrials.gov registry was searched to identify all trials concerning AMD. Trials that were actively recruiting, not interventional, terminated, or did not actually concern AMD were excluded. Only trials completed 2 or more years before this analysis was started were included, to allow for adequate time to pass before publication was expected to occur. PubMed.gov was then searched to evaluate the publication status of each study. RESULTS: Three hundred and eight-six studies were initially identified, and 64 (16.5%) were included in the final evaluation. Three hundred and twenty-one studies were not included for the following reasons: 171 did not involve AMD or were not interventional; 141 were not completed by January 1, 2007; and 9 trials were terminated. Of the 64 trials included, 35 (54%) were published. Early phase trials were published at a lower rate (41.6% [15/36]) than late-phase trials (71.4% [20/28]). This difference was statistically significant (P = 0.02). The sponsor type, date of study initiation, and location did not influence the publication rate. CONCLUSION: Using broad study parameters, 54% of registered interventional clinical trials in AMD have been reported in the peer-reviewed literature.

Scleral Buckle Removal: Indications, Timing, Complications, and Long-Term Outcomes.

BACKGROUND AND OBJECTIVE: To report indications, timing, complications, and outcomes of scleral buckle (SB) removal surgery. PATIENTS AND METHODS: Retrospective observational case series. Eyes that underwent SB removal between 2010 and 2016 with greater than 1 year of follow-up were included. Main outcome measures were post-SB removal complications and best-corrected visual acuity (BCVA). RESULTS: Fifty eyes that underwent SB removal met the inclusion criteria. Indications include exposed SB (54%), infection (26%), diplopia (16%), and recurrent retinal detachment (4%). Mean and median intervals between SB placement and removal were 65 months and 30 months. Complications include recurrent retinal detachment (12%), transient ocular hypertension (6%), and persistent diplopia (4%). There was no significant change in mean BCVA after SB removal (P = .979). CONCLUSIONS: Exposed SB, infection, and diplopia are the most common indications for SB removal. The single-surgery success rate is high and the risk for complications is relatively low. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:138-144.].

Two-year interim safety results of the 0.2 µg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: the observational PALADIN study.

BACKGROUND: The 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, 'real-world' safety results for the FAc implant in DMO. METHODS: This 24-month interim analysis of a prospective, observational study investigated patients with DMO receiving the commercially available intravitreal 0.2 µg/day FAc implant. The primary outcome was incidence of intraocular pressure (IOP)-lowering procedures. Other IOP-related signals and their relationship to previous corticosteroid exposure, best-corrected visual acuity, central subfield thickness (CST), ocular adverse events and frequency of other treatments were also measured. RESULTS: Data were collected from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant. Mean IOP for the overall population remained stable post-FAc compared with pre-FAc implant. IOP-related procedures remained infrequent (two IOP-lowering surgeries pre-FAc; two trabeculoplasties and four IOP-lowering surgeries post-FAc). Mean visual acuity was stable post-FAc (mean improvement of 1-3 letters) and fewer DMO treatments were required per year following FAc implant. Mean CST was significantly reduced at 24 months post-FAc implant (p<0.001) and the percentage of patients with CST ≤300 µm was significantly increased (p=0.041). CONCLUSION: Few IOP-related procedures were reported during the 24 months post-FAc implant. Positive efficacy outcomes were noted after treatment, with stabilisation of vision and reduction in inflammation, demonstrated by CST. The FAc implant has a favourable benefit-risk profile in the management of DMO, especially when administered after a prior steroid challenge. TRIAL REGISTRATION NUMBER: NCT02424019.

Optimizing DME Treatment With Decreased Injection Frequency Using Long-Term Steroid Implants.

BACKGROUND AND OBJECTIVE: Anti-vascular endothelial growth factor (VEGF) agents are the first-line treatment for diabetic macular edema (DME) based on randomized, control trials from the early 2000s. However, the efficacy of anti-VEGF is limited in clinical practice because its monthly injection schedule is logistically challenging for most working-age patients. PATIENTS AND METHODS: Recent large-scale, randomized, control trials have demonstrated that intravitreal corticosteroid implants provide efficacious long-term treatment for DME. RESULTS: Intravitreal corticosteroid implants block a wide spectrum of inflammatory factors involved in DME pathogenesis, with each implant lasting from months to years. Intravitreal corticosteroid implants also have the pharmacokinetic advantage over anti-VEGF agents in vitrectomized eyes. CONCLUSIONS: Although anti-VEGF agents have lower bioavailability in vitrectomized eyes due to rapid clearance, intravitreal corticosteroid implants are not significantly affected by vitrectomy in bioavailability or efficacy. Side effects of intravitreal corticosteroid implants include cataract formation and ocular hypertension, both of which are manageable with appropriate monitoring. Taken together, intravitreal corticosteroid implants serve as a convenient, efficacious, and long-term treatment for patients with DME. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:S22-S29.].

Long-term incidence and timing of intraocular hypertension after intravitreal triamcinolone acetonide injection.

PURPOSE: To describe the long-term incidence and timing of steroid-induced ocular hypertension after intravitreal triamcinolone acetonide (IVTA) therapy. DESIGN: Retrospective case series of 929 eyes of 841 patients. PARTICIPANTS: Patients with a variety of posterior segment disorders in a single group practice. INTERVENTION: Pars plana injection of IVTA. MAIN OUTCOME MEASURES: Intraocular pressure (IOP) and requirement for glaucoma surgery. RESULTS: Overall, 929 eyes received >or=1 injections (mean, 1.6) of 4 mg of IVTA. During a mean follow-up period of 14+/-6.9 months, the Kaplan-Meier cumulative incidences of IOP elevations >21 mmHg at 6, 12, 18, and 24 months post-injection were 28.2%, 34.6%, 41.2%, and 44.6%, respectively; similarly, the incidences of eyes with IOP measurements >25 mmHg were 14.6%, 19.1%, 24.1%, and 28.2%, respectively. At the same time points, IOP-lowering medications were required by 13.0%, 16.9%, 20.7%, and 24.2% of eyes, respectively. Only 3 eyes (0.3%) required IOP-lowering surgery. Preexisting glaucoma, younger age, and a history of an IOP elevation after a previous IVTA injection were risk factors for IOP elevations after IVTA injection. The minimum and maximum follow-up were 3 weeks and 37 months. The mean rate of attrition in this study was 3% per month. CONCLUSIONS: Elevations in IOP after IVTA injection are common. Younger patients and eyes with preexisting glaucoma or a history of a steroid response should be monitored more closely for IOP elevations after IVTA therapy.

Intravitreal triamcinolone acetonide preceding photodynamic therapy for exudative age-related macular degeneration.

BACKGROUND AND OBJECTIVE: To evaluate the efficacy of intravitreal triamcinolone acetonide 1 week before photodynamic therapy (PDT) with verteporfin in the treatment of exudative age-related macular degeneration (AMD). PATIENTS AND METHODS: Retrospective chart review of 70 eyes of 66 consecutive patients who were treated with intravitreal triamcinolone acetonide followed by standard PDT 1 week later. Group 1 consisted of 42 eyes that received one or more previous treatments with PDT alone and responded poorly. Group 2 consisted of 28 eyes that had never received PDT. RESULTS: No statistically significant change in mean visual acuity was seen during the follow-up period for either group. At 12 months, 90% of group 1 eyes and 80% of group 2 eyes lost less than 2 lines of Snellen visual acuity. A mean of 1.24 additional PDT sessions were required in group 1 eyes and 1.04 additional sessions in group 2 eyes during the follow-up period. CONCLUSION: In eyes with exudative AMD, intravitreal triamcinolone acetonide preceding PDT with verteporfin results in stabilization of visual acuity and a decreased need for re-treatments with PDT. This regimen may be superior to PDT monotherapy.

RELENTLESS PLACOID CHORIORETINITIS: SUCCESSFUL LONG-TERM TREATMENT WITH INTRAVITREAL TRIAMCINOLONE.

PURPOSE: To report a case of relentless placoid chorioretinitis (ampiginous choroiditis) treated with intravitreal triamcinolone acetonide (IVTA). METHODS: Interventional case report. RESULTS: A 34-year-old pregnant woman with a history of poor visual acuity in her left eye, secondary to an undetermined cause, developed an acute painless central scotoma and blurred vision in the right eye. The examination revealed decreased visual acuity, active inflammatory placoid choroidal lesions in the posterior pole, and mid-periphery with sharp disk margins and normal-appearing vasculature. A diagnosis of relentless placoid chorioretinitis was made, and the patient was treated biannually with 4 mg IVTA for 3 years with visual improvement to 20/25. Although she experienced a relapse at 12 months, the episode was adequately controlled with repeat IVTA. After the sixth IVTA treatment occurring at 30 months, the decision was made to stop IVTA, ultimately facilitating the preservation of 20/25 in the right eye at 63-month follow-up. The disease course was complicated by cataract progression that was successfully treated with a cataract extraction and episodic increases in intraocular pressure which were successfully treated with timolol ophthalmic solution. CONCLUSION: Intravitreal triamcinolone acetonide therapy represents an important alternative in the treatment of relentless placoid chorioretinitis. By avoiding the potentially significant side effects of long-term systemic corticosteroid and immunosuppressive therapies, IVTA can be an important alternative in the long-term management of this uncommon and complicated entity.

The temporal sequence of combined intravitreal triamcinolone acetonide and photodynamic therapy for exudative age-related macular degeneration.

BACKGROUND AND OBJECTIVE: To compare visual acuity results in patients with exudative age-related macular degeneration treated with two different temporal sequences of combination intravitreal triamcinolone acetonide and photodynamic therapy with verteporfin. PATIENTS AND METHODS: A retrospective, comparative, interventional case series was used. Thirty-one eyes received intravitreal triamcinolone acetonide 1 week prior to photodynamic therapy, and 30 eyes received intravitreal triamcinolone acetonide followed by photodynamic therapy the same day. RESULTS: There was no significant difference in visual acuity between the groups at baseline (P = .084), 6 to 12 weeks of follow-up (P = .085), or 1 year of follow-up (P= .093). When visual acuity outcomes were adjusted for baseline visual acuity, spot size, lesion type, age, and gender, there was no significant difference in visual acuity at 6 to 12 weeks (P = .44) or 1 year (P= .28). CONCLUSIONS: There appears to be no significant difference in visual outcomes in eyes with exudative age-related macular degeneration treated with intravitreal triamcinolone acetonide 1 week prior to photodynamic therapy or those treated with intravitreal triamcinolone acetonide on the same day as photodynamic therapy.