NCT04358471

Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA)

A Phase 2 Multi-Center Trial Evaluating Intravitreal AAVCAGsCD59 Compared to Sham Injection for the Treatment of Advanced Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hemera Biosciences · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection. All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59.

Conditions

• Dry Age-related Macular Degeneration
• Geographic Atrophy
• Gene Therapy
• Intravitreal Injection

Interventions

Type	Name	Description
BIOLOGICAL	Intravitreal AAVCAGsCD59	AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye
OTHER	Intravitreal Sham Injection	Sham injection mimics a real injection in the enrolled eye

Timeline

• Start date: 2021-07-31
• Primary completion: 2023-07-01
• Completion: 2023-09-01
• First posted: 2020-04-24
• Last updated: 2021-05-10

Regulatory

• FDA-regulated drug study