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

NCT00969293 | Terminated Phase 1 DMC

• 1 other identifier: FOV2302/CLIN/101/P
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Macular Edema; Central Retinal Vein Occlusion

Keywords

Macular Edema; Occlusive retinal vascular disease; Central Retinal Vein Occlusion; CRVO

Outcome Measures

Primary Outcomes (1)

• 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

  3 months post-dose

Secondary Outcomes (1)

• 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

  3 months post-dose

Interventions

FOV2302 (Ecallantide) DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fovea Pharmaceuticals SA: lead

Study Sites (8)

CHU d'Amiens, Centre Saint-Victor

Amiens, 80054, France

Location

Centre Intercommunal de Creteil

Créteil, 94010, France

Location

CHU de Dijon, Hôpital Général

Dijon, 21000, France

Location

Clinique Monticelli

Marseille, 13008, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Centre Hospitalier National d'Ophthalmologies des XV-XX

Paris, 75012, France

Location

Hopital Lariboisiere

Paris, 75015, France

Location

Fondation Rothschild

Paris, 75571, France

Location

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Interventions

ecallantide

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alain Gaudric, MD

  Hopital Lariboisiere

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: March 1, 2012
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

FR (8)