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 (FOV2302)
Primary Purpose
Macular Edema, Central Retinal Vein Occlusion
Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
FOV2302 (Ecallantide)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring Macular Edema, Occlusive retinal vascular disease, Central Retinal Vein Occlusion, CRVO
Eligibility 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).
Sites / Locations
- CHU d'Amiens, Centre Saint-Victor
- Centre Intercommunal de Creteil
- CHU de Dijon, Hôpital Général
- Clinique Monticelli
- CHU de Nantes
- Centre Hospitalier National d'Ophthalmologies des XV-XX
- Hopital Lariboisiere
- Fondation Rothschild
Outcomes
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
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
Full Information
NCT ID
NCT00969293
First Posted
August 31, 2009
Last Updated
January 9, 2012
Sponsor
Fovea Pharmaceuticals SA
1. Study Identification
Unique Protocol Identification Number
NCT00969293
Brief Title
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
Acronym
FOV2302
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fovea Pharmaceuticals SA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Central Retinal Vein Occlusion
Keywords
Macular Edema, Occlusive retinal vascular disease, Central Retinal Vein Occlusion, CRVO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
FOV2302 (Ecallantide)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Gaudric, MD
Organizational Affiliation
Hopital Lariboisiere
Official's Role
Study Chair
Facility Information:
Facility Name
CHU d'Amiens, Centre Saint-Victor
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Intercommunal de Creteil
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU de Dijon, Hôpital Général
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Clinique Monticelli
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier National d'Ophthalmologies des XV-XX
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Fondation Rothschild
City
Paris
ZIP/Postal Code
75571
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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