Study design | Treatment arms | Primary outcomes | Results | Author conclusions | Real-world impact | Clinical Study “Common” Name (formal title) |
---|---|---|---|---|---|---|
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. | 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] | Lampalizumab, a selective complement factor D inhibitor, did not reduce the enlargement of GA lesions vs sham. [Holz.JAMA Ophth.2018] |
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 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. | Two phase 3, double-masked, multicenter, randomized, sham injection-controlled studies. |
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) |
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 |