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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03940690
Other study ID # FME_2018_9
Secondary ID
Status Suspended
Phase Phase 3
First received
Last updated
Start date October 24, 2019
Est. completion date November 2024

Study information

Verified date February 2024
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 30
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
Device:
Laser
3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9

Locations

Country Name City State
France Centre hospitalier René Dubos (Pontoise) Cergy-Pontoise
France Fondation Ophtalmologique A. de Rothschild Paris
France Hôpital Universitaire Necker Enfants Malades, APHP Paris
France CHU de Reims Reims
France Clinique Rive Gauche Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with improvement of stage of disease, according to the Shields classification 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
See also
  Status Clinical Trial Phase
Completed NCT04089995 - Coats Plus Syndrome and LCC Syndrome: Series of 10 Pediatric Cases. Review of Literature and Natural History
Completed NCT04310631 - Evaluation of Retinal and Vascular Features in Coats Disease After Intravitreal Injections of Ranibizumab