CHROMA: Clinical Trial of Lampalizumab for Geographic Atrophy Secondary to Age-Related Macular Degeneration 29/01/2015
Phase III clinical studies have been initiated for Lampalizumab, an investigational drug for geographic atrophy (GA), the advanced form of age-related macular degeneration (AMD), a progressive condition which can result in blindness. The phase III study program will evaluate the safety and efficacy of Lampalizumab and its potential to slow the progression of GA. The studies will also further explore if people with a specific genetic biomarker, a mutation in complement factor I, may benefit more from Lampalizumab treatment.
These phase III trials, called Chroma (GX29176) and Spectri (GX29185), are identically-designed, double-masked, randomized studies evaluating 10 mg dose of Lampalizumab administered every 4 or 6 weeks by intravitreal injection to sham injections. Approximately 936 patients will be enrolled in each study from approximately 300 physician-investigator sites in 24 countries worldwide.
Key inclusion criteria
Include the presence of geographic atrophy in both eyes with no history of neovascular (wet) AMD.
The primary objective is to demonstrate a reduction in the rate of GA disease progression. This efficacy endpoint, evaluated at one year, is defined as the mean change in the GA lesion area of the chosen study eye from baseline.
Secondary objectives, planned for evaluation at two years, focus on assessing the impact of Lampalizumab treatment on patients’ visual function. If successful, it is planned to continue through a subsequent, open-label extension study.
Lampalizumab, developed by Roche (Basel, Switzerland), is being investigated to determine its effect on the progression of GA associated with advanced AMD.
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Our team of professionals will answer you as soon as possible and we will assess whether you are eligible.
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