Clinical Study “Common” Name (formal title) Study design Treatment arms Primary outcomes Results Author conclusions Real-world impact
CHROMA
(A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration)
 
SPECTRI
(A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration)
Two phase 3, double-masked, multicenter, randomized, sham injection-controlled studies. Lampalizumab 10 mg every 4 weeks, through 96 weeks.
Sham every 4 weeks, through 96 weeks.
Lampalizumab 10 mg every 6 weeks, through 96 weeks.
Sham every 6 weeks, through 96 weeks.
Mean change from baseline in GA lesion area at week 48 from centrally read fundus autofluorescence images of the lampalizumab arms vs pooled sham arms, in the intent-to-treat population and by complement factor I–profile genetic biomarker. No meaningful differences at week 48 were identified among eyes receiving lampalizumab 10 mg either every 4 weeks or every 6 weeks vs sham.
[Holz.JAMA Ophth.2018]
Lampalizumab, a selective complement factor D inhibitor, did not reduce the enlargement of GA lesions vs sham. [Holz.JAMA Ophth.2018] SPECTRI and CHROMA were the largest, most comprehensive phase 3 trials in dry AMD at the time, assessing the impact of lampalizumab on geographic atrophy. [Holz.JAMA Ophth.2018]
The phase 3 trials showed that lampalizumab was ineffective as a treatment of geographic atrophy secondary to AMD. Some have hypothesized that the results were expected given the non-significant p value in the phase 2 study which was used to power the phase 3 study. [Holz.JAMA Ophth.2018]
DERBY/OAKS
(Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy [GA] Secondary to Age-Related Macular Degeneration)
Two phase 3, multicenter, randomized, double-masked, sham-controlled studies APL-2 15mg 0.1 mL Monthly for 24 months
APL-2 15mg 0.1 mL Every Other Month for 24 months
Sham Procedure Monthly for 24 months
Sham Procedure Every Other Month for 24 months
[NCT03525613/Arms and Interventions]
Change from baseline to month 12 in total area of GA lesion(s) in the study eye based on fundus autofluorescence
[NCT03525613/Outcome Measures]
N/A N/A N/A