NCT00969293

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

An Open-label, Dose Escalating 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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Fovea Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Occlusive retinal vascular disease is not uncommon. Central retinal vein occlusion (CRVO) is the second most common vision-impairing vascular disorder of the retina following diabetic retinopathy. Severe visual loss from CRVO is caused by a combination of retinal edema and neovascular proliferation and ischemia. Vascular endothelial factors as they stimulate angiogenesis and increase vascular permeability, are majors pathogenic factors in CRVO. Counteracting these neovascular effects provide significant therapeutic benefit to subjects suffering from this disorder. Macular edema in this condition results from a conjunction of several, as yet, partially unknown factors. Macular edema may occur in diseases causing cumulative injury over many years, such as diabetic retinopathy, or as a result of more acute events, such as branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Conditions

• Macular Edema
• Central Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	FOV2302 (Ecallantide)	Single intravitreal injection into the relevant eye. Five dose levels will be studied from 5 to 90µg and a maximum of 6 subjects will be included at each dose level. Duration of Treatment: Single injection with 3 months follow-up.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-07-01
• Completion: 2012-03-01
• First posted: 2009-09-01
• Last updated: 2012-01-10

Locations

8 sites across 1 country: France