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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05678517
Other study ID # SE RKB 168/2022
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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