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 - Full Text View

Sponsor:	Fovea Pharmaceuticals SA
Information provided by (Responsible Party):	Fovea Pharmaceuticals SA
ClinicalTrials.gov Identifier:	NCT00969293

Purpose

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.

Condition	Intervention	Phase
Macular Edema Central Retinal Vein Occlusion	Drug: FOV2302 (Ecallantide)	Phase I

Study Type:	Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Ecallantide

U.S. FDA Resources

Further study details as provided by Fovea Pharmaceuticals SA:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	11
Study Start Date:	September 2009
Estimated Study Completion Date:	March 2012
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969293

Locations

France
CHU d'Amiens, Centre Saint-Victor
Amiens, France, 80054
Centre Intercommunal de Creteil
Creteil, France, 94010
CHU de Dijon, Hôpital Général
Dijon, France, 21000
Clinique Monticelli
Marseille, France, 13008
CHU de Nantes
Nantes, France, 44093
Centre Hospitalier National d'Ophthalmologies des XV-XX
Paris, France, 75012
Hopital Lariboisiere
Paris, France, 75015
Fondation Rothschild
Paris, France, 75571

Sponsors and Collaborators

Fovea Pharmaceuticals SA

Investigators

Study Chair:

Alain Gaudric, MD

Hopital Lariboisiere

More Information

No publications provided

Responsible Party:	Fovea Pharmaceuticals SA
ClinicalTrials.gov Identifier:	NCT00969293 History of Changes
Other Study ID Numbers:	FOV2302/CLIN/101/P
Study First Received:	August 31, 2009
Last Updated:	January 9, 2012
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Fovea Pharmaceuticals SA:

Macular Edema
Occlusive retinal vascular disease
Central Retinal Vein Occlusion
CRVO

Additional relevant MeSH terms:

Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases

Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012