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Understanding geographic atrophy disease progression through visual function endpoints: the lampalizumab clinical trial program

Session Details

Session Title: AMD I

Session Date/Time: Thursday 17/09/2015 | 08:30-10:30

Paper Time: 09:26

Venue: Athena

First Author: : J.Monés SPAIN

Co Author(s): :    E. Henry   C. Brittain           

Abstract Details

PURPOSE:Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by retinal pigment epithelium/photoreceptor degeneration and progressive, irreversible vision loss. Although the fovea is rarely atrophic in early GA, patients often report visual dysfunction that is not reflected in best-corrected visual acuity (BCVA) measurement. Visual function endpoints that may better capture the dysfunction experienced by patients compared with standard, high-contrast, black-on-white ETDRS chart letters will be evaluated in the lampalizumab clinical trial program.

Setting:

Chroma (NCT02247479) and Spectri (NCT02247531) are 2 identically-designed, double-masked, randomized, phase 3 trials enrolling approximately 936 patients per trial at more than 275 investigator sites in more than 20 countries. Proxima A and B are two separate, parallel, prospective, observational studies with a combined enrollment target of 560 patients globally.

Methods:

Chroma and Spectri will evaluate the efficacy and safety of intravitreal lampalizumab 10 mg administered every 4 or 6 weeks versus sham injections in patients with bilateral GA secondary to AMD. Each treatment group will include both complement factor I (CFI) genetic biomarker-positive and CFI genetic biomarker-negative patients. In the phase 2 MAHALO study, CFI appeared to be both prognostic for GA progression and predictive of lampalizumab treatment response. Key inclusion criteria for the phase 3 studies are similar to that of MAHALO. The Proxima study program will provide natural history data on visual function changes in patients with GA. Proxima A will include 360 patients with inclusion criteria similar to the phase 3 population, and Proxima B will include 200 patients with GA phenotypes different from the phase 3 population, including unilateral GA and GA with choroidal neovascularization in the fellow eye.

Results:

The main objective of Chroma and Spectri is to demonstrate a reduction in GA area progression in patients treated with lampalizumab, as compared with sham control. The primary efficacy endpoint is defined as the mean change in GA lesion area of the study eye from baseline at one year, as measured by fundus autofluorescence. Secondary endpoints will evaluate the effect of lampalizumab compared with sham on visual function (microperimetry and reading speed test), vision-related patient-reported outcomes questionnaires at two years, and both high-contrast best-corrected and low-luminance visual acuity. The relationship between GA lesion progression and visual function changes will also be evaluated in the Proxima study program. In the Proxima cohorts, patients will be followed every 6 months, with imaging and functional assessments similar to the phase 3 studies. The Proxima studies will also further investigate the prognostic nature of the CFI genetic biomarker.

Conclusions:

The lampalizumab clinical trial program includes 4 studies and will enroll more than 2400 patients with GA. The Chroma and Spectri phase 3 studies will evaluate the efficacy and safety of lampalizumab in reducing GA lesion progression, and will comprehensively assess visual function using tools that may better demonstrate the impact of GA on patients as compared with typical BCVA. Proxima A and B will provide additional information on the anatomic and functional progression of GA in phase 3-like patients as well as a broader GA population.

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