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French Evaluation Group Avastin Versus Lucentis (GEFAL)

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Avastin
Lucentis
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Age-related Macular Degeneration, Bevacizumab, Ranibizumab

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service d'Ophtalmologie - Hôpital de la Croix Rousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Avastin

Lucentis

Arm Description

intravitreal injection of bevacizumab

intravitreal injection of ranibizumab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2010
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01170767
Brief Title
French Evaluation Group Avastin Versus Lucentis
Acronym
GEFAL
Official Title
French Evaluation Group Avastin Versus Lucentis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Age-related Macular Degeneration, Bevacizumab, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
501 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avastin
Arm Type
Experimental
Arm Description
intravitreal injection of bevacizumab
Arm Title
Lucentis
Arm Type
Active Comparator
Arm Description
intravitreal injection of ranibizumab
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lucentis
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluate and compare the efficacy of treatments by bevacizumab and ranibizumab
Time Frame
12 months
Title
Evaluate and compare the proportion of adverse events occurring at the local and systemic level in the two groups.
Time Frame
12 months
Title
Describe and compare the dosage regimen (average number of injections and time before re-injection) in the two groups
Time Frame
12 months
Title
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
Title
Create a medico-economic model of the impact related to the two strategies.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent KODJIKIAN
Organizational Affiliation
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Ophtalmologie - Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23916488
Citation
Kodjikian L, Souied EH, Mimoun G, Mauget-Faysse M, Behar-Cohen F, Decullier E, Huot L, Aulagner G; GEFAL Study Group. Ranibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial. Ophthalmology. 2013 Nov;120(11):2300-9. doi: 10.1016/j.ophtha.2013.06.020. Epub 2013 Aug 2.
Results Reference
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French Evaluation Group Avastin Versus Lucentis

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