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

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ClinicalTrials.gov Identifier: NCT03940690
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 24, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940690


Contacts
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Contact: Laurence SALOMON, MD PhD 148036433 ext +33 lsalomon@for.paris

Locations
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France
Centre hospitalier René Dubos (Pontoise) Not yet recruiting
Cergy-Pontoise, France, 95303
Contact: Bernard PASQUIER       bernard.pasquier@ght-novo.fr   
Hôpital Universitaire Necker Enfants Malades, APHP Not yet recruiting
Paris, France, 75015
Contact: Dominique BREMOND-GIGNAC       dominique.bremond@aphp.fr   
Fondation Ophtalmologique A. de Rothschild Recruiting
Paris, France, 75019
Contact: Florence METGE       fmetge@for.paris   
Contact: Georges CAPUTO       gcaputo@for.paris   
CHU de Reims Not yet recruiting
Reims, France, 51092
Contact: Carl ARNDT       carndt@chu-reims.fr   
Clinique Rive Gauche Not yet recruiting
Toulouse, France, 31000
Contact: Léopoldine LEQUEUX       drlequeux@gmail.com   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Florence METGE fmetge@for.paris

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03940690     History of Changes
Other Study ID Numbers: FME_2018_9
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Retinal Telangiectasis
Telangiectasis
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors