French Evaluation Group Avastin Versus Lucentis (GEFAL)

May 23, 2019 updated by: Hospices Civils de Lyon

Age Related Macular Degeneration (AMD) is the first cause of visual impairment in elderly patients in industrialized countries. Neovascular or "wet" AMD, characterized by the presence of choroïdal neovessels, represents the most aggressive form of the disease. Its prevalence is 3.3% among patients older than 65 years in Europe, and increases with age.

Intraocular injections of anti-angiogenic monoclonal antibodies (ranibizumab) to treat AMD have appeared recently. It is derived from a larger sized molecule, bevacizumab, which do not have the market authorization for this indication. However, numerous publications of case series seem to show the effectiveness and a satisfactory safety profile of bevacizumab.

These conclusions have to be confirmed with a high level of evidence study. The aim of the GEFAL study is to demonstrate non-inferiority of effectiveness in clinical terms after 12 months of treatment with bevacizumab compared to ranibizumab on the visual acuity of patients affected by neovascular AMD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

501

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69317
        • Service d'Ophtalmologie - Hôpital de la Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 50 years old
  • Affected by neovascular retrofoveal AMD whatever the subtype, unilateral or bilateral (the eye included will be chosen by the investigator and the patient);
  • Best corrected VA for the studied eye ranging between 20/32 (6.3/10) and 20/320 (0.6/10) with ETDRS scale
  • Size of lesion < 12 disk area
  • In case of occult neovessels, proof required of recent development of the lesion: loss of VA of at least 5 letters ETDRS (equivalent one line) in the last 3 months OR appearance of a subretinal heamorrhage OR increase in the size of the lesion (> 10%) using fluoresceinic angiography during the last month by comparison with the last 3 months OR appearance of OCT criteria of macular oedema type, serous separation of neuro-epithelium, separation of the pigmented epithelial during the last month
  • Effective birth control for sexually active female
  • Signed informed consent.

Exclusion Criteria:

  • Previous or actual treatment with intravitreal injection of an anti-VEGF drug (ranibizumab, bevacizumab or pegaptanib) in the studied eye
  • Other healing treatment in the studied eye during the last 3 months before the first injection
  • Medical history of photocoagulation in the studied eye
  • Involvement in another clinical study (studied eye and/or the other eye)
  • Subretinal haemorrhage reaching the fovea centre, with a size > 50% of the lesion area
  • Fibrosis or retrofoveal retinal atrophy in the studied eye
  • Retinal pigment epithelial tear reaching the macula in the studied eye
  • Choroidal neovascularisation not related to a DMLA in the studied eye
  • Medical history of intravitreal medical device in the studied eye
  • Active or suspected ocular or peri-ocular infection
  • Serious active intra-ocular inflammation in the studied eye
  • Medical history of auto-immune or idiopathic uveitis
  • Proved diabetic retinopathy
  • Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
  • Medical history of intra-ocular surgery within 2 months before the first injection in the studied eye
  • Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
  • Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
  • Known hypersensitivity to ranibizumab, bevacizumab, or another drug composite of the medicinal products used; allergy to fluorescein, indocyanin green, anaesthetic eye drops
  • Arterial hypertension that is not controlled by an appropriate treatment
  • Previous or actual treatment with systemic administration of bevacizumab
  • Follow up not possible during 12 months
  • No affiliation to the French national health insurance program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Avastin
intravitreal injection of bevacizumab
Drug: Avastin
Intravitreal injection of bevacizumab at a concentration of 1.25 mg per injection. One injection per month at the maximum and between 3 and 12 injection in the whole study.
Active Comparator: Lucentis
intravitreal injection of ranibizumab
Drug: Lucentis
Intravitreal injection of ranibizumab at a concentration of 0.50 mg per injection. One injection per month at the maximum and between 3 and 12 injection in the whole study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the mean change from inclusion to 12 months post initiation of treatment in VA score, measured on the "Early Treatment Diabetic Retinopathy Study" (ETDRS) scale at an initial distance of 4 meters.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate and compare the efficacy of treatments by bevacizumab and ranibizumab
Time Frame: 12 months
12 months
Evaluate and compare the proportion of adverse events occurring at the local and systemic level in the two groups.
Time Frame: 12 months
12 months
Describe and compare the dosage regimen (average number of injections and time before re-injection) in the two groups
Time Frame: 12 months
12 months
Describe the pharmacokinetic profile of the drugs in blood and aqueous humor in a sub-group of 20 patients, during the induction stage.
Time Frame: 3 months
3 months
Create a medico-economic model of the impact related to the two strategies.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Laurent KODJIKIAN, Hospices Civils de Lyon - Hôpital de la Croix-Rousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 26, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007.467/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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