A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Geographic Atrophy
- Macular Degeneration
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Masking Description: Participant, "Evaluating" Investigator, Reading Center Personnel, and Sponsor Personnel are maskedPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
Description
Patients will be randomized in a 1:1 ratio to the following monthly treatment groups: Zimura 2 mg Sham At month 12, the patients in the Zimura 2mg treatment group will be re-randomized to receive the study drug either on a monthly basis or on an every other month basis The patients initially randomi...
Patients will be randomized in a 1:1 ratio to the following monthly treatment groups: Zimura 2 mg Sham At month 12, the patients in the Zimura 2mg treatment group will be re-randomized to receive the study drug either on a monthly basis or on an every other month basis The patients initially randomized to Sham treatment will continue with monthly Sham injections through Month 23 All patients will have a final follow up visit at Month 24
Tracking Information
- NCT #
- NCT04435366
- Collaborators
- Not Provided
- Investigators
- Not Provided
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