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French Evaluation Group Avastin Versus Lucentis (GEFAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01170767
First received: July 26, 2010
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
 Drug: Avastin
Drug: Lucentis
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: French Evaluation Group Avastin Versus Lucentis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate and compare the efficacy of treatments by bevacizumab and ranibizumab [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Evaluate and compare the proportion of adverse events occurring at the local and systemic level in the two groups. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Describe and compare the dosage regimen (average number of injections and time before re-injection) in the two groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Create a medico-economic model of the impact related to the two strategies. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170767

Locations
France
Service d'Ophtalmologie - Hôpital de la Croix Rousse
Lyon, France, 69317
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Laurent KODJIKIAN Hospices Civils de Lyon - Hôpital de la Croix-Rousse
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01170767     History of Changes
Other Study ID Numbers: 2007.467/10
Study First Received: July 26, 2010
Last Updated: February 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Age-related Macular Degeneration
Bevacizumab
Ranibizumab

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013