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 |
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Recruitment Status :
Recruiting
First Posted : May 7, 2019
Last Update Posted : February 15, 2023
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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 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 2024 |
| Estimated Study Completion Date : | November 2024 |
| Arm | Intervention/treatment |
|---|---|
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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
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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) |
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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
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Device: Laser
3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9 |
- 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 |
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
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
| Contact: Amélie YAVCHITZ, MD PhD | 148036433 ext +33 | ayavchitz@for.paris |
| France | |
| Centre hospitalier René Dubos (Pontoise) | 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 | Recruiting |
| Reims, France, 51092 | |
| Contact: Carl ARNDT carndt@chu-reims.fr | |
| Clinique Rive Gauche | Recruiting |
| Toulouse, France, 31000 | |
| Contact: Léopoldine LEQUEUX drlequeux@gmail.com | |
| Principal Investigator: | Florence METGE | fmetge@for.paris |
| Responsible Party: | Fondation Ophtalmologique Adolphe de Rothschild |
| ClinicalTrials.gov Identifier: | NCT03940690 |
| Other Study ID Numbers: |
FME_2018_9 |
| First Posted: | May 7, 2019 Key Record Dates |
| Last Update Posted: | February 15, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Retinal Telangiectasis Coats Disease Anti-VEGF (Vascular Endothelial Growth Factor) |
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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 |