Phase 2
Completed N=4
A Study to Establish the Safety and Tolerability of Zimura™ (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
Idiopathic Polypoidal Choroidal Vasculopathy
Source: ClinicalTrials.gov NCT02397954 ↗
Enrolled (actual)
4
Serious AEs
25.0%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants With >15 ETDRS Letter Loss at Month 3 — 0 Participants
Summary
The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With >15 ETDRS Letter Loss at Month 3 |
— | — |
| PRIMARY Number of Participants With Ophthalmic Adverse Events |
3 | — |
| PRIMARY Number of Participants With Systemic Adverse Events |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects of either gender aged ≥ 50 years
- Diagnosis of IPCV
- Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8 injections in the previous twelve (12) months
Exclusion Criteria
- 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 prior to entry
- History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant
- Previous therapeutic radiation in the region of the study eye
- A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy and/or leakage from retinal vasculature in a subject with diabetes mellitus)
Data sourced from ClinicalTrials.gov (NCT02397954). 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.