OPH1013
Research type
Research Study
Full title
A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration.
IRAS ID
280108
Contact name
Louise Downey
Contact email
Sponsor organisation
IVERIC bio, Inc.
Eudract number
2020-000676-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 15 days
Research summary
Age-related macular degeneration (AMD) is an aging disease characterized by damage to the macula, a small area in the central portion of the retina, responsible for central vision. As the disease progresses to the advanced stage with age, it generally turn into the “wet” or the “dry” form. In the dry, atrophic form, loss of photoreceptors, RPE (retinal pigment epithelium) cells and associated capillaries in the macula results in geographic atrophy (thinning of atrophy of retinal tissue) which is a significant cause of bilateral, irreversible and severe loss of functional vision. Further, development of geographic atrophy over time is also common in patients with the wet form of advanced AMD who are treated with Anti-VEGF (vascular endothelial growth factor) therapy.
Although there is currently treatment for patients with wet AMD, currently there is no approved therapy for geographic atrophy.
This is a global, multicentre, randomised, double blind, placebo controlled phase-3 study to test how effective and safe Zimura (complement C5 inhibitor) when administered in patients with geographic atrophy secondary to dry age-related macular degeneration.
About 400 participants will take part in this study
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0117
Date of REC Opinion
17 Jun 2020
REC opinion
Further Information Favourable Opinion