| Study name |
A study of danicopan in participants with geographic atrophy secondary to age‐related macular degeneration |
| Methods |
Phase 2, controlled, randomised, double‐blind, parallel group study at multiple centres |
| Participants |
Adults 60 years and older with GA due to AMD in at least one eye. Participants with prior history of intravitreal anti‐vascular endothelial growth factor therapy and a known/suspected complement deficiency are excluded |
| Interventions |
Danicopan administered as an oral tablet at 100 mg twice a day, 200 mg twice a day, or 400 mg four times a day, as compared to placebo oral tablet at an equivalent frequency of administration |
| Outcomes |
Primary outcome measure:
Secondary outcome measures:
Change in the square root of total GA lesion area in the study eye as measured by FAF (time frame: 104 weeks) Change in the total GA lesion area in the study eye as measured by FAF (time frame: 52 and 104 weeks) Change in monocular BCVA scores in the study eye as assessed by the ETDRS chart (time frame: 52 and 104 weeks) Change in monocular LLVA scores in the study eye as assessed by the ETDRS chart (time frame: 52 and 104 weeks) Change from baseline in LLD in the study eye (time frame: 52 and 104 weeks) Change in monocular reading speeds in the study eye (time frame: 52 and 104 weeks) Plasma concentration of danicopan over time (time frame: 4 hours post‐dose) PD biomarkers, ex vivo serum alternative pathway activity, and plasma Bb concentration over time (time frame: 4 hours post‐dose) Change in VFQ‐25 scores (time frame: 52 and 104 weeks) Incidence of treatment‐emergent, serious, and ocular AEs, and clinical laboratory abnormalities, and events leading to discontinuation of study drug (time frame: 104 weeks)
|
| Starting date |
August 2021 |
| Contact information |
Alexion Pharmaceuticals, MA, USA |
| Status |
Recruiting |
| Required reporting date |
February 2025 |
| Notes |
— |
