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

Sponsor

Semmelweis University (Other)

Overall Status

Completed

CT.gov ID

NCT05678517

Collaborator

(none)

Enrollment

Locations

155.1

Actual Duration (Months)

23.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	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 Design

Study Type:

Observational

Actual Enrollment :

47 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 6, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients Patients with AMD	Drug: Anti-VEGF intravitreal ranibizumab or intravitreal aflibercept

Arm

Intervention/Treatment

Patients

Patients with AMD

Drug: Anti-VEGF

intravitreal ranibizumab or intravitreal aflibercept

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, Semmelweis University	Budapest		Hungary	1085
2	Department of Ophthalmology, Bajcsy-Zsilinszky Hospital	Budapest		Hungary

Sponsors and Collaborators

Semmelweis University

Investigators

Principal Investigator: Andras Papp, MD, PhD, Semmelweis University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Papp András, Associate Professor, Semmelweis University

ClinicalTrials.gov Identifier:

NCT05678517

Other Study ID Numbers:

SE RKB 168/2022

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 10, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Macular Degeneration

Study Results

No Results Posted as of Jan 10, 2023