A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneratio

Phase 1

• Conditions: Geographic Atrophy (AD) secondary to Age-related Macular Degeneration (AMD).; MedDRA version: 20.1Level: LLTClassification code 10063947Term: Geographic atrophySystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2021-001198-22-ES
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-30
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Key Inclusion Criteria:
• Age = 70 years, male or female
• Presentation of GA secondary to AMD in at least 1 eye.
• Study eye must have the specified VA (range of 84 to 4 letters; 20/20 to 20/800) using Early Treatment Diabetic Retinopathy Study charts at starting distance of 4 meters.
• GA area of 0.5 to 17.76 mm2 (~0.25 to 7 disc area [DA]) per eye
measured by FAF
• The entire GA lesion must be extrafoveal without foveal involvement
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 330

Exclusion Criteria

Key Exclusion Criteria:
• GA in either eye due to cause other than AMD.
• Have previously received intravitreal anti-vascular endothelial growth factor injections in study eye.
• Have previously received any complement/stem cell/gene therapy for any ophthalmological condition.
• Previous participation in interventional clinical studies for treatment of drusen, nascent GA or GA (except vitamins or minerals) irrespective of route of administration (ocular or systemic) in either eye.
• Presence of active ocular diseases in either eye that in the opinion of the Investigator compromises or confounds visual function or interferes with study assessments.
• Known or suspected complement deficiency.
• History or presence of any clinically relevant co-morbidities or any
uncontrolled conditions.
• Hypersensitivity to fluorescein sodium for injection, the
investigational drug (danicopan) or any of its excipients.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified