The MAHALO Phase IB/II trial preceded SPECTRI and CHROMA. MAHALO was a cohort study of 108 fellow untreated eyes of 143 patients with GA resulting from AMD. Comparing optical coherence tomography images at baseline and 18 months after the start of treatment with lampalizumab, the MAHALO study authors concluded that GA lesions seemed to enlarge at a slower rate in eyes with outer retinal tabulation (ORT) than in eyes without ORT.
Neil B. Bressler, MD, of Wilmer Eye Institute, Baltimore, and chair of the trials’ Executive Advisory Committee, answered questions via e-mail about the twin trials.
Q How do CHROMA and SPECTRI differ from the MAHALO phase II trial?
A SPECTRI and CHROMA are Phase III studies being done in parallel, whereas MAHALO was a Phase II study. The Phase II study was designed to determine if it was feasible to proceed with a Phase III trial. The Phase III trials are designed to identify, confidently, if there is a benefit, with acceptable safety, of lampalizumab in the management of geographic atrophy from age-related macular degeneration.
Q What are the primary and secondary endpoints of the twin trials?
A The primary outcome is change in geographic atrophy area from baseline, as assessed by retinal imaging. The key secondary outcomes include change in best-corrected visual acuity from baseline and change in additional measures of visual function.
Q How many centers will participate in the trials?
A Approximately 275 centers are anticipated to enroll study participants across more than 20 countries around the world between CHROMA and SPECTRI.
Q How many patients will ultimately be enrolled?
A SPECTRI and the similarly designed CHROMA trials are anticipated to enroll 936 patients in each study.
Q When will enrollment cease?
A Enrollment likely will cease when the planned sample size of 936 study participants has been attained in each study, assuming enrollment is being completed in a timely fashion and no substantive changes to the protocol are undertaken that might affect this plan.
|Long Story Short: |
CHROMA and SPECTRI
Formal study title: A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration. (SPECTRI and CHROMA share the same title.)
SPECTRI, NCT02247531; CHROMA, NCT02247479.
Q Are the studies accepting any more centers/investigators?
A At this point there are no plans to add new sites to CHROMA-SPECTRI, but there are other studies being planned in GA. Sites can contact Roche (Genentech in the United States) if interested.
Q How would they contact the trial leaders?
A Investigators interested in discussing possible participation in the study can contact Roche (www.roche.com/about_roche/roche_worldwide.htm) and reference Study ID Number: GX29176.
Q When would the earliest Phase III results be available?
A After the last patient enrolls, that last study participant will reach the primary outcome one year later and complete the last study visit two years later. Additional time, is needed to analyze the data and prepare a report for regulatory authorities. These processes dictate how soon the results would be available. RS