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1.
Retina ; 2024 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-38718277
3.
Ophthalmologie ; 2024 Apr 18.
Artigo em Alemão | MEDLINE | ID: mdl-38634948

RESUMO

BACKGROUND: Susac syndrome (SS) describes an endotheliopathy of vessels in the central nervous system. Retinal involvement plays a central role in the manifestation of the disease. OBJECTIVE: This case-control study investigated the macular microvasculature in patients with chronic SS compared to controls using optical coherence tomography angiography (OCTA). MATERIAL AND METHODS: 12 eyes of 12 patients with SS were compared with age-matched healthy control subjects with regard to their OCT angiographic parameters. The flow density (FD) of different macular layers, foveal avascular zone (FAZ) parameters and central retinal thickness and volume values were compared between the two groups. RESULTS: The FD of the choriocapillaris was reduced in Susac patients compared to healthy controls. The FD values of the superficial and deep capillary plexus of the inner retina, parameters of the FAZ as well as central retinal thickness and volume showed no significant differences between the two groups. DISCUSSION: Treated chronic SS does not appear to significantly affect the vascular and structural composition of the central inner retina; however, differences in the choriocapillaris indicate changes in deeper, highly vascularized capillary layers.

4.
Diagnostics (Basel) ; 14(7)2024 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-38611620

RESUMO

Keratoconus (KC) is the most common corneal ectasia. Optical coherence tomography angiography (OCT-A) is a relatively new non-invasive imaging technique that allows the visualization and quantification of retinal and choriocapillary blood vessels. The aim of this study is to assess retinal and choriocapillary vessel density (VD) differences between KC patients and healthy controls and to investigate correlations between VD and KC severity. Fifty-two eyes were included in this exploratory study: twenty-six eyes from 26 KC patients and twenty-six eyes from 26 age- and gender-matched healthy controls. All patients underwent Scheimpflug corneal topography with Pentacam, axis lengths measurement and optical coherence tomography angiography (OCT-A). The thinnest spot in corneal pachymetry, maximum K (Kmax) and KC severity indices from the Belin/Ambrósio enhanced ectasia display (BAD) were also assessed. There was a distinct reduction particularly in the retinal VD of the superficial capillary plexus (SCP). Correlation analyses showed strong and moderate negative correlations between the VD in the macular SCP and BAD KC scores and between the SCP VD and Kmax. There was no difference in retinal thickness between the KC and healthy controls. With this study, further evidence for altered VD measurements by OCT-A in KC patients is given. For the first time, we demonstrated negative correlations between BAD KC scores and retinal blood vessel alterations. A major limitation of the study is the relatively small sample size. Since an artefactual reduction of the quantitative OCT-A measurements due to irregular corneal topography in KC must be assumed, it remains to be investigated whether there are also actual changes in the retinal microcirculation in KC.

5.
Z Psychosom Med Psychother ; 70(1): 24-34, 2024 Feb.
Artigo em Alemão | MEDLINE | ID: mdl-38598705

RESUMO

OBJECTIVES: To investigate macular and peripapillary vascular density (VD) in patients with anorexia nervosa (AN) compared to healthy controls. Methods:Whole face scans of the superficial and deep macular layers and whole face and peripapillary scans of the radial peripapillary capillaries (RPC) were obtained using optical coherence tomography angiography (OCTA, AngioVueR, Optovue) in ten patients with AN and ten age-matched controls.The primary objective was to determine whether there was a difference between the vessel density (VD) in the above areas in AN and controls. P-values ≤ 0.0125 were considered statistically significant. Results: VD in the superficialmacular en-face OCTA image was significantly lower in the study group compared to the control group. Neither the deepmacula nor the radial peripapillary capillary (RPC) in the whole-face image nor the RPC-peripapillary imaging appeared to be significantly different. Conclusion: Patients with AN showed reduced VD in the superficialmacular layers compared to healthy controls, which can be discussed as a consequence of the malnutrition. OCTA could be a useful non- invasive tool to detect reduced peripheral blood supply to show vascular changes that occur before ocular symptoms.


Assuntos
Anorexia Nervosa , Disco Óptico , Humanos , Disco Óptico/irrigação sanguínea , Angiofluoresceinografia/métodos , Vasos Retinianos , Densidade Microvascular , Projetos Piloto , Tomografia de Coerência Óptica/métodos , Anorexia Nervosa/diagnóstico
6.
Artigo em Inglês | MEDLINE | ID: mdl-38670121

RESUMO

Congenital nasolacrimal duct obstruction (CNLDO) is the most common cause of epiphora in the first year of life. In addition to conservative therapy, there are several invasive methods available. The aim of this retrospective study was to conduct a long-term follow-up of bicanalicular lacrimal duct intubation as the primary intervention in a large cohort of patients with CNLDO. The electronic medical records of 487 patients with CNLDO who underwent bicanalicular tube intubation were reviewed. To determine the long-term outcomes, a telephone interview was conducted. A total of 328 eyes of 235 patients were included in the study. The median average follow-up period was 6.67 (5.58 - 8.67) years. At the time of the survey, 218 patients (92.8%) were symptom free. Mean patient satisfaction with surgical outcome was 10/10. To our knowledge, this study provides the longest follow-up of the largest patient cohort in the literature consisting of patients who underwent probing with bicanalicular lacrimal silicone tube intubation as a primary intervention for CNLDO. This study showed a high long-term postoperative success rate, with high postoperative satisfaction, few complications, and a low need for reintervention.

9.
Ophthalmologie ; 121(5): 385-390, 2024 May.
Artigo em Alemão | MEDLINE | ID: mdl-38363379

RESUMO

BACKGROUND: Intravitreal medication injections are an efficient and low-risk delivery technique for treating various retinal diseases. Rare serious complications include increased intraocular pressure, vitreous hemorrhage, retinal tears and detachment, intraocular inflammation and endophthalmitis. In the case series presented here, we report iatrogenic lens injuries caused by inadequate performance of intravitreal injections. METHODS: A multicenter data collection of patients treated with intravitreal injections with visible iatrogenic lens defects from 2016 to 2023 was retrospectively performed. RESULTS: Lens trauma after intravitreal injections was identified in six cases (69.3±6.5 years). While five cases were observed after anti-VEGF therapy, we identified lens injury after dexamethasone implantation in one patient. CONCLUSION: Iatrogenic lens injury during intravitreal injection is preventable with the correct injection technique. Knowledge of individual axis length and lens status also helps to avoid this complication.


Assuntos
Injeções Intravítreas , Cristalino , Humanos , Injeções Intravítreas/efeitos adversos , Idoso , Masculino , Estudos Retrospectivos , Feminino , Pessoa de Meia-Idade , Cristalino/lesões , Cristalino/efeitos dos fármacos , Doença Iatrogênica/prevenção & controle , Traumatismos Oculares/induzido quimicamente , Inibidores da Angiogênese/efeitos adversos , Inibidores da Angiogênese/administração & dosagem , Dexametasona/administração & dosagem , Dexametasona/uso terapêutico , Dexametasona/efeitos adversos , Idoso de 80 Anos ou mais
10.
Ophthalmologie ; 121(3): 196-206, 2024 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-38315190

RESUMO

INTRODUCTION: Digitalization in medicine, especially the electronic documentation of patient data, is revolutionizing healthcare systems worldwide. The evaluation of real-world data collected under everyday conditions presents opportunities but also challenges. Electronic medical registries provide a means to compile extensive patient data for scientific inquiries. Oregis is the first nationwide digital registry for health services research established by the German Ophthalmological Society (DOG). Intravitreal operative medicinal injections (IVOM) are among the most frequently performed procedures in ophthalmology. Data on injection numbers and injection frequencies with anti-vascular endothelial growth factor (VEGF) are already available from other countries, whereas data at a national level are not yet available in Germany due to the lack of a nationwide register. It is known that the treatment success of anti-VEGF IVOMs depends largely on the adherence to treatment and thus on the number of injections. There are also differences in cost. In the context of this study, real-world data on the frequency and distribution of intravitreal injections in German centers from 2015 to 2021 were compiled for the first time since the introduction of oregis. The aim of this study is to collect data on the use of anti-VEGF IVOMs in Germany from oregis for the first time and to show the development of injection numbers and anti-VEGF drugs used. At the same time, the possibilities of data retrieval from oregis are demonstrated using a concrete example from daily ophthalmological practice. MATERIAL AND METHODS: An automated query of records was performed for all patients who received IVOM at oregis-affiliated healthcare facilities between 2015 and 2021. The number of treated patients and the use of anti-VEGF medications, including aflibercept, bevacizumab, brolucizumab, and ranibizumab, were determined. The data were collected in a pseudonymized and anonymized manner. RESULTS: At the time of data collection, 9 German ophthalmological healthcare facilities were affiliated with oregis. In total, 309,152 patients were registered during the observation period, with 8474 receiving IVOMs. Over the observation period, the number of participating centers, patients, and intravitreal injections increased. The proportional share of anti-VEGF agents among the total number of injections varied during the observation period. DISCUSSION: Real-world data captured in oregis offer significant potential for enhancing healthcare provision. Oregis enables the depiction of ophthalmological care conditions in Germany and contributes to research and quality assurance. The ability to query the presented data exemplifies the multitude of inquiries through which oregis can contribute to the representation of ophthalmological care in Germany.


Assuntos
Inibidores da Angiogênese , Fator A de Crescimento do Endotélio Vascular , Humanos , Injeções Intravítreas , Ranibizumab/uso terapêutico , Bevacizumab/uso terapêutico
11.
Ophthalmol Ther ; 13(4): 979-994, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38345711

RESUMO

INTRODUCTION: To investigate the long-term outcomes of emergency penetrating keratoplasty using cryopreserved human donor corneas in the management of actual or imminent corneal perforation. METHODS: A retrospective analysis was performed of the treatment efficacy of emergency penetrating keratoplasty using a cryopreserved human donor cornea, in 14 eyes of 14 patients with corneal ulcers of different etiology. For comparison, the medical histories of 14 patients who had undergone penetrating keratoplasty with the same indication, but received a regularly processed human corneal graft, were retrospectively analyzed. In both groups, the primary endpoint for graft failure was repeat surgery, defined as the necessity for amniotic membrane transplantation, conjunctival flap, or repeat penetrating keratoplasty, during a follow-up time of maximally 12 months. RESULTS: The difference in the need for repeated surgeries between the cryopreserved human donor cornea group and cultivated tissue graft group was not statistically significant (p = 0.835). Specifically, repeat complex surgery of any kind within 6 months was necessary in 50% of the cryopreserved cornea group and in 57.1% of the control group, with no further surgical interventions during the remainder of the follow-up period. However, repeat penetrating keratoplasty occurred more frequently in the cryopreserved cornea group (n = 5) than in the control group (n = 1) during the first 12 months after treatment (p = 0.048). CONCLUSION: Cryopreserved corneas appear to be a viable option for promptly addressing emergencies and stabilizing the corneal situation, providing a faster solution compared to waiting for fresh tissue availability. However, repeat penetrating keratoplasty is more frequent when cryopreserved human donor corneas are used. Cryopreserved human donor corneas may be useful if surgical treatment is urgent and alternative options, such as tissue use, a conjunctival flap, or multilayer amniotic membrane transplantation, are not available.

12.
Ophthalmologica ; 2024 Feb 16.
Artigo em Inglês | MEDLINE | ID: mdl-38368867

RESUMO

BACKGROUND: The German Registry of Central serous chorioretinopathy (CSC) collects data on CSC patients in a nationwide multicenter approach to analyze epidemiology, risk factors, clinical presentations as well as diagnosis and treatment patterns. MATERIAL AND METHODS: In this multicenter cohort study, patients with CSC were enrolled in nine tertiary referral centers in Germany between January 2022 and June 2023. After consenting to the study, demographic data, risk factors, reported symptoms, best corrected visual acuity (BCVA), funduscopic findings, disease severity, and diagnostic and treatment decisions were recorded and analyzed. RESULTS: A total of 539 eyes of 411 CSC patients were enrolled in this study including 308 male (75%) and 103 female (25%). Patients were predominantly of Caucasian origin and had a mean age of 55.5 years (IQR 41.0 - 70.0). 28% of eyes were classified as acute (<4 months duration) CSC, 28% as chronic (>4 months duration) CSC, 21% as inactive CSC, 11% as chronic atrophic CSC, and 12% as CSC with secondary CNV. 128 patients (31%) demonstrated bilateral CSC. The most common risk factors reported were psychological stress (52%), smoking (38%), arterial hypertension (38%), and a history of or current use of steroids (30%). Most frequently encountered symptoms included decreased visual acuity (76%), metamorphopsia (49%), relative scotoma (47%), blurred vision (19%), and dyschromatopsia (9%). Mean logMAR BCVA on initial examination was 0.2 (≈20/30, IQR 0.2 - 0.4), but showed significant variation with a tendency of lower BCVA in chronic cases. At the baseline visit, 74% of the overall cohort received no treatment, while 19% underwent local treatment and only 2% systemic treatment. Of the local therapies, anti-VEGF injections were the most frequently performed procedure (33%, mainly for secondary CNV), followed by micropulse laser (28%), focal non-pulsed laser (23%), photodynamic therapy (14%), and nonsteroidal anti-inflammatory eye drops (2%). Among intravitreal anti-VEGF agents, aflibercept was used most frequently, followed by bevacizumab and ranibizumab. DISCUSSION: This registry represents one of the largest cohorts of European patients with CSC to date. Patient age and the proportion of women was higher than expected and bilateral active disease was lower than anticipated, highlighting that neither age nor gender should be overemphasized when diagnosing CSC. Therapeutic interventions are heterogeneous and include photodynamic therapy, micropulse laser and anti-VEGF injections in case of secondary CNV.

13.
Ophthalmologica ; 2024 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-38266500

RESUMO

BACKGROUND: The aim of this review is to systematically summarize the current knowledge on Type 3 Macular Neovascularization' (MNV3) in age-related macular degeneration (AMD). SUMMARY: Recent histopathologic and multimodal imaging findings led to the consensus definition of the new term 'Type 3 Macular Neovascularization' in AMD. MNV3 originates in the deep vascular plexus as a neovascular process without connection with the retinal pigment epithelium in the initial stages. This type has numerous clinical and pathomorphologic features that separate it from the other two types of MNV in AMD. Besides, its frequency appears to be higher than previously thought. In optical coherence tomography (OCT), MNV3 can be classified in stage 1-3. Hyperreflective foci in the outer retina possibly represent a precursor lesion. In addition, MNV3 is characterized by a strong association with reticular pseudodrusen, a high rate of bilaterality, close associations with advanced age and arterial hypertension, decreased choroidal thickness, and decreased choriocapillaris flow signals. Data from latest anti vascular endothelial growth factor (VEGF) studies in MNV3 suggest that the OCT biomarkers intraretinal and subretinal fluid should be interpreted differently than in the other types. Additionally, data from MNV3 eyes should be analyzed separately allowing optimal type-specific treatment strategies in the future. KEY MESSAGES: This review highlights the need for accurate characterization of nAMD lesions and an MNV type-specific approach, particularly for MNV3.

14.
Ophthalmologie ; 121(2): 129-134, 2024 Feb.
Artigo em Alemão | MEDLINE | ID: mdl-38214731

RESUMO

BACKGROUND: Intravitreal operative drug injections represent one of the most frequently performed medical interventions. The risk profile is low. In addition to intraocular pressure elevation, the most frequent complications include exogenous endophthalmitis, vitreous hemorrhage and rhegmatogenous retinal detachment. Furthermore, isolated cases of lens injuries, macular holes associated with vitreoretinal traction and peripheral retinal defects have been described. In the present case series sharp iatrogenic macular and retinal defects are described. METHODS: Retrospective multicenter case collection of patients with iatrogenic retinal defects after intravitreal injections from 2016 to 2023. RESULTS: Iatrogenic retinal trauma after intravitreal injections for treatment of neovascular age-related macular degeneration was identified in 9 cases (72 years ± 8.1, 3 eyes pseudophakic). While sharp injuries within the macula occurred in six cases, extramacular lesions were detected in the other cases. CONCLUSION: Iatrogenic retinal and macular injuries are rare complications of intravitreal injections and when correctly carried out are preventable, especially with respect to use of cannulas and the choice of the distance from the limbus.


Assuntos
Oftalmopatias , Descolamento Retiniano , Doenças Retinianas , Humanos , Idoso , Injeções Intravítreas , Doenças Retinianas/tratamento farmacológico , Oftalmopatias/tratamento farmacológico , Descolamento Retiniano/cirurgia , Doença Iatrogênica
15.
Diagnostics (Basel) ; 14(2)2024 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-38248087

RESUMO

BACKGROUND: Optical coherence tomography angiography (OCT-A) provides detailed visualization of the perfusion of the vascular network of the eye. While in other forms of dementia, such as Alzheimer's disease and mild cognitive impairment, reduced retinal perfusion was frequently reported, data of patients with frontotemporal dementia (FTD) are lacking. OBJECTIVE: Retinal and optic nerve head perfusion was evaluated in patients with FTD with OCT-A. Quantitative OCT-A metrics were analyzed and correlated with clinical markers and vascular cerebral lesions in FTD patients. METHODS: OCT-A was performed in 18 eyes of 18 patients with FTD and 18 eyes of 18 healthy participants using RTVue XR Avanti with AngioVue. In addition, patients underwent a detailed ophthalmological, neurological, and neuropsychological examination, cerebral magnetic resonance imaging (MRI), and lumbar puncture. RESULTS: The flow density in the optic nerve head (ONH) and in the superficial capillary plexus (SCP) of the macula of patients was significantly lower compared to that of healthy controls (p < 0.001). Similarly, the VD in the deep capillary plexus (DCP) of the macula of patients was significantly lower compared to that of healthy controls (p < 0.001). There was no significant correlation between the flow density data, white matter lesions in brain MRI, cognitive deficits, and cerebrospinal fluid markers of dementia. CONCLUSIONS: Patients with FTD showed a reduced flow density in the ONH, and in the superficial and deep retinal capillary plexus of the macula, when compared with that of healthy controls. Quantitative analyses of retinal perfusion using OCT-A may therefore help in the diagnosis and monitoring of FTD. Larger and longitudinal studies are necessary to evaluate if OCT-A is a suitable biomarker for patients with FTD.

16.
Artigo em Inglês | MEDLINE | ID: mdl-38240777

RESUMO

BACKGROUND/AIM: The aim of this paper is to compare retinal nerve fiber layer thickness (RNFL) and Bruch's membrane opening-based minimum rim width (BMO-MRW) in terms of their performance in detecting early and moderate/advanced glaucoma using receiver operating characteristics (ROC) analysis and the classification using the 5th percentile as a cut-off. METHODS: One hundred eyes from 100 patients with early glaucoma (mean deviation (MD): < -5.0 dB) and 100 eyes from 100 patients with moderate/advanced glaucoma (MD: > -5.0 dB) were carefully matched to healthy controls based on optic disc size. Then, the dataset was divided, based on the 50th percentile of the measured Bruch's membrane opening area (BMO-A), into small (BMO-A < 1.95 mm2) and large optic discs (BMO-A > 1.95 mm2). Finally, the discriminative performance of BMO-MRW and RNFL between glaucoma and controls using ROC analysis and the manufacturer's classification based on the 5th percentile was analyzed. RESULTS: In discriminating between glaucoma and matched healthy controls, global BMO-MRW and global RNFL thickness had comparable areas under the ROC curve for eyes with early glaucoma and both small BMO-As (ROC ± confidence interval [CI] 0.91 [0.87 to 0.95] and 0.88 [0.83 to 0.93]) and large BMO-As (0.86 [0.82 to 0.92] and 0.84 [0.79 to 0.90]), as well as in moderate/advanced glaucoma with small BMO-As (0.99 [0.98 to 1.00] and 0.97 [0.95 to 1.00]) and large BMO-As (0.94 [0.91 to 0.98] and 0.97 [0.94 to 1.00]). Using the calculated 5th percentile as a threshold value, the sensitivities for the detection of early and moderate/advanced glaucoma were comparable for BMO-MRW and RNFL in eyes with small optic discs (early glaucoma: fifty-two percent and 61%; moderate/advanced glaucoma: ninety-one percent and 92%). In eyes with large optic discs, the sensitivity of BMO-MRW was inferior to that of RNFL for both early (38% versus 51%) and moderate/advanced (80% versus 91%) glaucoma. CONCLUSION: Based on an ROC analysis, the discriminative performance of BMO-MRW and RNFL between patients with early and moderate/advanced glaucoma and a healthy control group matched based on optic disc size is comparable in eyes with BMO-As smaller and larger 1.95 mm2. Using a classification based on the 5th percentile, as used in clinical practice, RNFL is shown to be superior to BMO-MRW regarding sensitivity in glaucoma detection with large optic discs. This study underscores the importance of RNFL imaging and measurement in the diagnostic evaluation of glaucoma, especially in cases of large optic discs.

17.
Eye (Lond) ; 38(1): 54-60, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37479803

RESUMO

Anti-VEGF therapies are associated with significant gains in visual acuity and fluid resolution in the treatment of diabetic macular oedema (DMO) and have become the standard of care. However, despite their efficacy, outcomes can be unpredictable, vary widely between individual eyes, and a large proportion of patients have persistent fluid following initial treatment, with a negative impact on visual outcomes. Anatomical parameters measured by optical coherence tomography (OCT), in addition to visual acuity, are key to monitoring treatment effectiveness and guiding retreatment decisions; however, existing guidelines on the management of DMO lack clear recommendations for interpretation of OCT parameters, or proposed thresholds of various markers to guide retreatment decisions. Although central subfield thickness (CSFT) has been widely used as a marker for retreatment decisions in clinical trials in DMO, and a reduction in CSFT has generally been shown to accompany improvements in best-corrected visual acuity with treatment, analyses of the relationship between these parameters show that the correlation is small to moderate. A more direct relationship can be seen between an increased magnitude of CSFT fluctuations over time and poorer visual acuity, suggesting that control of CSFT could be important in maximising visual outcomes. The relationship between visual outcomes and qualitatively assessed intraretinal fluid and subretinal fluid is also unclear, although quantitative assessments of fluid parameters suggest that untreated intraretinal fluid and subretinal fluid negatively impact visual outcomes. These findings highlight a need for clearer guidelines on the management of retinal fluid to improve visual outcomes for patients with DMO.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Retina , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/terapia , Retinopatia Diabética/complicações , Resultado do Tratamento , Tomografia de Coerência Óptica/métodos , Biomarcadores , Injeções Intravítreas , Inibidores da Angiogênese/uso terapêutico
19.
J Clin Med ; 12(23)2023 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-38068308

RESUMO

We compare the short- and mid-term postoperative outcomes of the iStent inject® with its successor, the iStent inject® W. A retrospective monocentric study was performed to compare the iStent inject® used for cataract surgery with the iStent inject® W, also used for cataract surgery. The primary study endpoint was intraocular pressure (IOP) reduction six months after surgery. Six-month follow-up results were available for 35 eyes from 27 patients in the iStent inject® group and for 32 eyes from 25 patients in the iStent inject® W group. IOP reduction at six months post surgery was significantly greater in the iStent inject® W group (-2.2 mmHg [iStent inject® W] vs. -0.06 mmHg [iStent inject®], p = 0.037). There was a statistically greater decrease in glaucoma medication administration at six months in the iStent inject® group than in the iStent inject® W group (-1.28 agents vs. -0.62 agents, p = 0.007). These findings support the hypothesis that the superior positioning of the iStent inject® W (due to its larger base diameter) compared to the iStent Inject® leads to greater IOP reduction. Because of the short follow-up period, small study cohort, and differences in the number of glaucoma patients, the study results must be interpreted carefully.

20.
Ophthalmology ; 2023 Dec 28.
Artigo em Inglês | MEDLINE | ID: mdl-38158159

RESUMO

PURPOSE: To evaluate the 2-year efficacy, durability, and safety of dual angiopoietin-2 and vascular endothelial growth factor (VEGF) A pathway inhibition with intravitreal faricimab according to a personalized treat-and-extend (T&E)-based regimen with up to every-16-week dosing in the YOSEMITE and RHINE (ClinicalTrials.gov identifiers, NCT03622580 and NCT03622593, respectively) phase 3 trials of diabetic macular edema (DME). DESIGN: Randomized, double-masked, noninferiority phase 3 trials. PARTICIPANTS: Adults with visual acuity loss (best-corrected visual acuity [BCVA] of 25-73 letters) due to center-involving DME. METHODS: Patients were randomized 1:1:1 to faricimab 6.0 mg every 8 weeks, faricimab 6.0 mg T&E (previously referred to as personalized treatment interval), or aflibercept 2.0 mg every 8 weeks. The T&E up to every-16-week dosing regimen was based on central subfield thickness (CST) and BCVA change. MAIN OUTCOME MEASURES: Included changes from baseline in BCVA and CST, number of injections, durability, absence of fluid, and safety through week 100. RESULTS: In YOSEMITE and RHINE (n = 940 and 951, respectively), noninferior year 1 visual acuity gains were maintained through year 2; mean BCVA change from baseline at 2 years (weeks 92, 96, and 100 average) with faricimab every 8 weeks (YOSEMITE and RHINE, +10.7 letters and +10.9 letters, respectively) or T&E (+10.7 letters and +10.1 letters, respectively) were comparable with aflibercept every 8 weeks (+11.4 letters and +9.4 letters, respectively). The median number of study drug injections was lower with faricimab T&E (YOSEMITE and RHINE, 10 and 11 injections, respectively) versus faricimab every 8 weeks (15 injections) and aflibercept every 8 weeks (14 injections) across both trials during the entire study. In the faricimab T&E arms, durability was improved further during year 2, with > 60% of patients receiving every-16-week dosing and approximately 80% receiving every-12-week or longer dosing at week 96. Almost 80% of patients who achieved every-16-week dosing at week 52 maintained every-16-week dosing without an interval reduction through week 96. Mean CST reductions were greater (YOSEMITE/RHINE weeks 92/96/100 average: faricimab every 8 weeks -216.0/-202.6 µm, faricimab T&E -204.5/-197.1 µm, aflibercept every 8 weeks -196.3/-185.6 µm), and more patients achieved absence of DME (CST < 325 µm; YOSEMITE/RHINE weeks 92-100: faricimab every 8 weeks 87%-92%/88%-93%, faricimab T&E 78%-86%/85%-88%, aflibercept every 8 weeks 77%-81%/80%-84%) and absence of intraretinal fluid (YOSEMITE/RHINE weeks 92-100: faricimab every 8 weeks 59%-63%/56%-62%, faricimab T&E 43%-48%/45%-52%, aflibercept every 8 weeks 33%-38%/39%-45%) with faricimab every 8 weeks or T&E versus aflibercept every 8 weeks through year 2. Overall, faricimab was well tolerated, with a safety profile comparable with that of aflibercept. CONCLUSIONS: Clinically meaningful visual acuity gains from baseline, anatomic improvements, and extended durability with intravitreal faricimab up to every 16 weeks were maintained through year 2. Faricimab given as a personalized T&E-based dosing regimen supports the role of dual angiopoietin-2 and VEGF-A inhibition to promote vascular stability and to provide durable efficacy for patients with DME. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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