A Phase 1 interventional study of FOV2302 (Ecallantide) in Macular Edema and Central Retinal Vein Occlusion, sponsored by Fovea Pharmaceuticals SA. Terminated at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-10.
Sponsored by Fovea Pharmaceuticals SA · Phase 1, Interventional, and Treatment
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.
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).
848 studies on the registry are indexed under Macular Edema; 57 are open to participants now.
This study's enrollment of 11 is below the median of 50 across 624 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Fovea Pharmaceuticals SA is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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
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
The record gives a start of Sep 2009, a primary completion of Jul 2011 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ecallantide
Fovea Pharmaceuticals SA