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

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05678517
• Other study ID #: SE RKB 168/2022
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 6, 2022

Study information

• Verified date: December 2022
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 6, 2022
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Anti-VEGF
intravitreal ranibizumab or intravitreal aflibercept

Locations

Country	Name	City	State
Hungary	Department of Ophthalmology, Bajcsy-Zsilinszky Hospital	Budapest
Hungary	Department of Ophthalmology, Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA	Best-corrected visual acuity	At the end of follow-up (year 7)
Primary	Geographic atrophy	Change in size of geographic atrophy on fundus autofluorescence (FAF)	At the end of follow-up (year 7)
Primary	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	Number of injections	Number of intravitreal anti-VEGF injections given	Over the course of the follow-up (7 years)
Secondary	Adverse events	Potential adverse events	Over the course of the follow-up (7 years)