French Evaluation Group Avastin Versus Lucentis

NCT01170767 | Completed Phase 3 DMC

• 1 other identifier: 2007.467/10
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

Age-related Macular Degeneration; Bevacizumab; Ranibizumab

Outcome Measures

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.

  12 months

Secondary Outcomes (5)

• Evaluate and compare the efficacy of treatments by bevacizumab and ranibizumab

  12 months

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

  12 months

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

  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.

  3 months

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

  12 months

Study Arms (2)

Avastin

EXPERIMENTAL

intravitreal injection of bevacizumab

Drug: Avastin

Lucentis

ACTIVE COMPARATOR

intravitreal injection of ranibizumab

Drug: Lucentis

Interventions

Avastin DRUG

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.

Avastin

Lucentis DRUG

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.

Lucentis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'Ophtalmologie - Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Related Publications (1)

• 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.

  PMID: 23916488 RESULT

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Laurent KODJIKIAN

  Hospices Civils de Lyon - Hôpital de la Croix-Rousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 28, 2019

Record last verified: 2013-02

Locations

FR (1)