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
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.
Central Retinal Vein Occlusion
Drug: FOV2302 (Ecallantide)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety and tolerability parameters to determine MTD: 1. Systemic parameters: adverse events (AEs), coagulation parameters (APTT, ACT) 2. Ophthalmologic parameters: BCVA, OCT, ocular inflammation, IOP [ Time Frame: 3 months post-dose ] [ Designated as safety issue: Yes ]
- Assess the pharmacodynamics up to five dose levels of a single administration of FOV2302 (ecallantide) by longitudinal measurements of the percent change of the macula thickness versus baseline as measured by OCT [ Time Frame: 3 months post-dose ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||March 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
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.
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).
|CHU d'Amiens, Centre Saint-Victor|
|Amiens, France, 80054|
|Centre Intercommunal de Creteil|
|Creteil, France, 94010|
|CHU de Dijon, Hôpital Général|
|Dijon, France, 21000|
|Marseille, France, 13008|
|CHU de Nantes|
|Nantes, France, 44093|
|Centre Hospitalier National d'Ophthalmologies des XV-XX|
|Paris, France, 75012|
|Paris, France, 75015|
|Paris, France, 75571|
|Study Chair:||Alain Gaudric, MD||Hopital Lariboisiere|