Zimura in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:11/11/2018
Start Date:January 2016

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A Phase 2b Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

The objectives of this study are to evaluate the safety and efficacy of intravitreous
administration of Zimura when administered in subjects with geographic atrophy (GA) secondary
to dry age-related macular degeneration (AMD).

Part 1: Approximately 66 subjects will be randomized in a 1:1:1 ratio to the following dose
groups:

- Zimura Dose Administration 1

- Zimura Dose Administration 2

- Sham Administration 1

Part 2: Approximately 135 subjects will be randomized in a 1:2:2 ratio to the following dose
groups:

- Zimura Dose Administration 3

- Zimura Dose Administration 4

- Sham Administration 2

Subjects will receive monthly intravitreal injections of Zimura or Sham for 18 months.

Inclusion Criteria:

- Subjects of either gender aged ≥ 50 years

- Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

- Evidence of Choroidal Neovascularization (CNV)

- GA secondary to any condition other than AMD

- Any prior treatment for AMD or any prior intravitreal treatment for any indication in
either eye, except oral supplements of vitamins and minerals

- Any intraocular surgery or thermal laser within three (3) months of trial entry

- Any prior thermal laser in the macular region, regardless of indication

- Any ocular or periocular infection in the twelve (12) weeks

- Previous therapeutic radiation in the region of the study eye

- Any sign of diabetic retinopathy in either eye
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52
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