Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and tolerability of a single administration of FOV2302 (ecallantide) in patients with macular edema associated with central retinal vein occlusion.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fovea Pharmaceuticals SA
• Treatments: Ecallantide

Criteria

Inclusion Criteria:

• Recent onset (< 6 months), non-ischemic CRVO (defined as association of documented retinal hemorrhage in all 4 quadrants of the retina with dilated veins) in patients who have not received treatment for their condition (e.g., no periocular depot or intraocular treatment [including corticosteroid and anti-VEGF], systemic corticosteroids or laser nor hemodilution).

• Retinal thickness measured by Stratus OCT > 250µm in the central subfield of study eye at baseline.

• BCVA score (measured by the ETDRS chart between 5 letters (20/800 Snellen equivalent) and 65 letters (20/50) in the study eye at baseline.

• Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.

• Females of childbearing potential using adequate birth control at Day 0 until study completion.

• Patient able (in the opinion of the investigator) and willing to return for all scheduled visits and assessments.

• Ability to read, understand and willingness to provide informed consent.

Exclusion Criteria:

• Rubeosis iridis or neovascular glaucoma at baseline.

• Preretinal neovascularisation at baseline.

• Ischemic CRVO, defined by more than 10 disc area of non-perfusion on fluorescein angiography at baseline.

• Any grade of diabetic retinopathy.

• Other eye condition that could contribute to macular edema or cause retinal vascular changes (including vitreomacular traction, uveitis and inflammatory disease, etc).

• Patients who have received treatment for their condition (e.g., no periocular depot or intraocular treatment [including corticosteroid and anti-VEGF], systemic corticosteroids or laser nor hemodilution).

• Ocular surgery (including cataract extraction, scleral buckle, etc.) and/or YAG capsulotomy within 3 months preceding treatment date or anticipated within the 3 months following treatment administration.

• Poorly controlled ocular hypertension and/or glaucoma (IOP greater than 25 mmHg despite maximal therapy).

• History of pars plana vitrectomy.

• Aphakia or anterior chamber intraocular lens.

• Presence of visible sclera thinning or ectasia.

• Presence of substantial cataract or other media opacity that, in the opinion of the investigator, is likely to interfere with visualization of the fundus or completion of study measurements.

• Any active ocular or peri-ocular infection (including conjunctivitis, chalazion or significant blepharitis).