COATS-VEGF: Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03940690
• Collaborator: (none)
• Enrollment: 30
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 60.3
• Patients Per Site: 6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Telangiectasis; Coats Disease	Drug: Anti-VEGF injections of bevacizumab; Device: Laser	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease
• Actual Study Start Date: Oct 24, 2019
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

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	Drug: Anti-VEGF injections of 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)
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	Device: Laser; 3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with improvement of stage of disease, according to the Shields classification [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier René Dubos (Pontoise)	Cergy-Pontoise		France	95303
2	Hôpital Universitaire Necker Enfants Malades, APHP	Paris		France	75015
3	Fondation Ophtalmologique A. de Rothschild	Paris		France	75019
4	CHU de Reims	Reims		France	51092
5	Clinique Rive Gauche	Toulouse		France	31000

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

• Principal Investigator: Florence METGE, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT03940690
• Other Study ID Numbers: FME_2018_9
• First Posted: May 7, 2019
• Last Update Posted: Dec 20, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild: Retinal Telangiectasis; Coats Disease; Anti-VEGF (Vascular Endothelial Growth Factor)
• Additional relevant MeSH terms: Retinal Telangiectasis; Telangiectasis; Bevacizumab

Study Results

No Results Posted as of Dec 20, 2021