Seven-year Outcomes Following Intensive Anti-VEGF Therapy in Wet AMD

Study Overview
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Brief Summary
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The aim of this study was to assess long-term benefits of intensive aflibercept and ranibizumab anti-VEGF therapy in patients with exudative AMD.

Detailed Description
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This study was conducted at two clinical sites in Budapest, Hungary after the Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (VIEW 2) phase-3 multicenter, prospective, randomized, double blind clinical trial (ClinicalTrials.gov ID: NCT00637377). Patients were treated with intravitreal anti-VEGF injections between 2008 and 2017. During the first 2 years in the framework of the VIEW 2 study, participants were randomized per protocol to intravitreal aflibercept or ranibizumab treatment arms and received injections according to the VIEW 2 study protocol. This study focused on long-term outcomes that happened after the VIEW 2 study. After finishing the VIEW 2 study, patients returned to daily routine medical care and were followed under regular clinical care in real-life conditions and were treated with predominantly ranibizumab anti-VEGF injections (participants received interventions as part of routine medical care). Treatment was administered as needed according to the judgement of the physician. Retreatment criteria were based on visual acuity, signs of activity on optical coherence tomography (OCT) or indirect slit lamp biomicroscopy. Results at the end of the follow-up (year 7) were retrospectively analyzed.

Official Title
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Seven-year Outcomes Following Intensive Anti-vascular Endothelial Growth Factor Therapy in Patients With Exudative Age-related Macular Degeneration

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Anti-VEGF


Participation Criteria
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Eligibility Criteria
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Same as the original VIEW2 study (NCT00637377) Finished VIEW 2 study

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with AMD | Drug: Anti-VEGF<br>* intravitreal ranibizumab or intravitreal aflibercept<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA | Best-corrected visual acuity | At the end of follow-up (year 7) | 
| Geographic atrophy | Change in size of geographic atrophy on fundus autofluorescence (FAF) | At the end of follow-up (year 7) | 
| Retinal fluid | Presence or absence of intra- or subretinal fluid on spectral-domain optical coherence tomography (OCT) | At the end of follow-up (year 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of injections | Number of intravitreal anti-VEGF injections given | Over the course of the follow-up (7 years) | 
| Adverse events | Potential adverse events | Over the course of the follow-up (7 years) |