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CompletedNCT01170767GEFALUpdated May 28, 2019

French Evaluation Group Avastin Versus Lucentis

A Phase 3 interventional study of Avastin and Lucentis in Age Related Macular Degeneration, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-05-28.

Sponsored by Hospices Civils de Lyon · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
501
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Age Related Macular Degeneration

Keywords

  • Age-related Macular Degeneration
  • Bevacizumab
  • Ranibizumab
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 501 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
501 participants (actual)

Study arms

  • Experimental
    Avastin

    intravitreal injection of bevacizumab

    Drug: Avastin

  • Active comparator
    Lucentis

    intravitreal injection of ranibizumab

    Drug: Lucentis

Interventions

  • DrugAvastin

    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.

  • DrugLucentis

    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.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Evaluate and compare the efficacy of treatments by bevacizumab and ranibizumab

    Time frame: 12 months

  2. Evaluate and compare the proportion of adverse events occurring at the local and systemic level in the two groups.

    Time frame: 12 months

  3. Describe and compare the dosage regimen (average number of injections and time before re-injection) in the two groups

    Time frame: 12 months

  4. 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

  5. Create a medico-economic model of the impact related to the two strategies.

    Time frame: 12 months

07

Study locations

1 site
  • Service d'Ophtalmologie - Hôpital de la Croix Rousse
    Lyon, 69317, France
08

References and documents

Publications

  • 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. PubMed 23916488 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01170767
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jul 27, 2010
Start date
Jun 2009
Primary completion
Dec 2012
Completion
Dec 2012
Last update
May 28, 2019

Study contacts

Laurent KODJIKIAN
principal investigator · Hospices Civils de Lyon - Hôpital de la Croix-Rousse

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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