Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease (COATS-VEGF)
Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease
Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Several treatment modalities are available and the choice of one of them depends on the stage of the disease and the habits of each center (laser photocoagulation, cryotherapy ...). VEGF (Vascular Endothelial Growth Factor) was found to be significantly elevated in the aqueous humor and subretinal fluid of patients with Coats disease. Several studies have shown the potential efficacy of intra-vitreous injections of anti-VEGF. But the results on their effectiveness have been evaluated only on small series of patients. Most published studies have analyzed their efficacy combined with another treatment, mainly laser photocoagulation. The true efficacy of anti-VEGF therapy as initial therapy, and then combined in Coats disease remains unknown. Currently, several centers are initiating first-line anti-VEGF injections, although no rigorous evaluation of this therapeutic strategy has been conducted.
The identification of the best treatment regimen will allow in the future the reduction of laser reprocessing and will ensure a better functional benefit in the affected patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Bourdeaux, France, 33076
- CHU de Bordeaux
-
-
France
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Cergy-Pontoise, France, France, 95303
- Centre hospitalier René Dubos (Pontoise)
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Paris, France, France, 75015
- Hôpital Universitaire Necker Enfants malades, APHP
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Paris, France, France, 75019
- Fondation Ophtalmologique A. de Rothschild
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Reims, France, France, 51092
- CHU de Reims
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Toulouse, France, France, 31000
- Clinique Rive Gauche
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Coats disease confirmed by fundus examination and fluorescein angiography
- Stage 2 or 3 at the fundus (Shields classification)
- Naive to any eye treatment on the eye affected by Coats disease
Exclusion Criteria:
- Other ocular pathology on the eye affected by Coats' disease
- Bilateral forms of the disease
- History of hypersensitivity to bevacizumab
- History of hypersensitivity to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies
- Allergic reaction in a previous fluorescein retinal angiogram
- Pregnancy or breastfeeding
- Active or suspected periocular infection
- Contraindication to treatments used for general anesthesia and morphine derivatives
- Cardiovascular, haemorrhagic and gastrointestinal risks
- Premature baby who has not reached the correct age of 37 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Anti-VEGF injections (bevacizumab)
5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9
|
5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9)
|
|
Active Comparator: Arm : laser only
3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9
|
3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients with improvement of stage of disease, according to the Shields classification
Time Frame: 6 months after randomization
|
Stages assessed by retinal multimodal imaging (retinophotography, optical coherence tomography when age allows, retinal fluorescein angiography) by two independent expert ophthalmologists
|
6 months after randomization
|
Collaborators and Investigators
Investigators
- Principal Investigator: Florence METGE, fmetge@for.paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FME_2018_9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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