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

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

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

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Drug: Anti-VEGF

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.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1085
    • Department of Ophthalmology, Semmelweis University
  • Budapest, Hungary
    • Department of Ophthalmology, Bajcsy-Zsilinszky Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Same as the original VIEW2 study (NCT00637377)
• Patients who finished the VIEW 2 study

Description

• Same as the original VIEW2 study (NCT00637377)
• Finished VIEW 2 study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with AMD	Drug: Anti-VEGF; intravitreal ranibizumab or intravitreal aflibercept

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: Andras Papp, MD, PhD, Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: December 28, 2022
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: SE RKB 168/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No