Fovista and Lucentis compared to Lucentis® alone in patients with AMD
Research type
Research Study
Full title
A PHASE 3 RANDOMISED, DOUBLE-MASKED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREOUS ADMINISTRATION OF FOVISTA (ANTI PDGF-B PEGYLATED APTAMER) ADMINISTERED IN COMBINATION WITH LUCENTIS® COMPARED TO LUCENTIS® MONOTHERAPY IN SUBJECTS WITH SUBFOVEAL NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
IRAS ID
136550
Contact name
Adnan Tufail
Contact email
Sponsor organisation
Ophthotech Corp.
Eudract number
2013-002997-33
Clinicaltrials.gov Identifier
Research summary
Age-related macular degeneration (AMD) is the leading cause of blindness in people over 50 years of age. It is caused by the breakdown of the central portion of the retina called the macula. The macula is responsible for the fine central vision in the eye that is needed for driving a car, reading fine print, recognising faces, etc.
Current treatment options include photocoagulation (a surgical procedure involving the application of a hot laser to seal and halt or slow the progression of abnormal blood vessels), photodynamic therapy (a procedure that uses a non-thermal or cold laser with an intravenous light sensitive drug to halt or slow the progression of abnormal retinal blood vessels), or a drug that is injected into the eye to halt or slow the progression of abnormal retinal blood vessels (such as Lucentis®, Eylea®, or Macugen® by itself, without Fovista™)
Fovista™ is an investigational drug being studied for the treatment of AMD. Fovista™ is given by injection into the vitreous, which is the clear, jelly-like substance that fills the middle of the eye.
Lucentis® is an approved drug for AMD, and is also given by injection into the vitreous. Lucentis® is known as an “anti-VEGF” agent. This means it blocks growth factor called “vascular endothelial growth factor”, which plays a major role in the onset of wet AMD.
The purpose of this study is to further measure the effects of Fovista™ in patients with ‘wet’ AMD, and how Fovista™ is absorbed into the body, when given in combination with Lucentis®.
The duration of the study is 24 months and over this time period patients will be treated with active Fovista™ or placebo in combination with Lucentis®.
The study is being sponsored by Opthotech Corp. and will take place at sites across Europe, Africa, Asia Pacific, North America, Latin America and the Middle East. It is anticipated that approximately 311 patients will be enrolled on each treatment cohort, totaling 622 participants in the trial.
REC name
London - Dulwich Research Ethics Committee
REC reference
13/LO/1686
Date of REC Opinion
11 Feb 2014
REC opinion
Further Information Favourable Opinion