Phase 2
Completed N=64
ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
Source: ClinicalTrials.gov NCT03362190 ↗Enrolled (actual)
64
Serious AEs
4.7%
Results posted
Feb 2022
Primary outcomePrimary: Systemic Adverse Events — 6; 5; 5; 11 Participants
Summary
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systemic Adverse Events |
6; 5; 5; 11; 0; 0 | — |
| PRIMARY Ophthalmic Adverse Events |
1; 1; 0; 2; 8; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Active subfoveal NVAMD
Exclusion Criteria
- History or evidence of severe cardiac disease
- Any major surgical procedure within one month of trial entry
- Subjects with a clinically significant laboratory value
- Any treatment with an investigational agent in the past 60 days for any condition
- Women who are pregnant or nursing
- Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
- Any prior treatment for AMD other than oral supplements of vitamins and minerals
Data sourced from ClinicalTrials.gov (NCT03362190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.