Phase 2 N=4 Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT02397954 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Jan 2019

Primary outcome: Primary: Number of Participants With >15 ETDRS Letter Loss at Month 3 — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Avacincaptad Pegol (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Ophthotech Corporation
Primary completion: Oct 2015

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	—

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).

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)

View full record on ClinicalTrials.gov →

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.