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)

Ophthotech

Status and phase

Completed

Phase 2

Conditions

Idiopathic Polypoidal Choroidal Vasculopathy

Treatments

Drug: Avacincaptad Pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT02397954

OPH2002

Details and patient eligibility

About

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).

Full description

Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye) in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea® 2 mg/eye).

Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3 compared to screening as measured by indocyanine green angiography (ICGA), and laboratory values.

Enrollment

4 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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)