Age-Related Macular Degeneration
Conditions
Brief summary
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
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.
Interventions
DRUGAnti-VEGF
intravitreal ranibizumab or intravitreal aflibercept
Sponsors
Semmelweis University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Same as the original VIEW2 study (NCT00637377) * Finished VIEW 2 study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCVA | At the end of follow-up (year 7) | Best-corrected visual acuity |
| Geographic atrophy | At the end of follow-up (year 7) | Change in size of geographic atrophy on fundus autofluorescence (FAF) |
| Retinal fluid | At the end of follow-up (year 7) | Presence or absence of intra- or subretinal fluid on spectral-domain optical coherence tomography (OCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of injections | Over the course of the follow-up (7 years) | Number of intravitreal anti-VEGF injections given |
| Adverse events | Over the course of the follow-up (7 years) | Potential adverse events |
Countries
Hungary
Outcome results
None listed