Coats disease
Conditions
Interventions
Trade Name: Avastin® (bevacizumab)
Pharmaceutical Form: Solution for infusion
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient = 16 years old - Coats disease confirmed by fundus examination and fluorescein angiography - Stage 2 or 3 at the fundus (Shields classification) on at least 2 quadrants - Naïve to any eye treatment on the eye affected by Coats disease Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of intravitreous injection (IVT) of anti-VEGF (bevacizumab, Avastin®) on the stage of Coats disease, compared to the reference treatment by laser photocoagulation, 6 months after initiation study treatment.; Secondary Objective: Compare the efficacy of anti-VEGF IVTs (bevacizumab, Avastin®) as an initial and adjuvant treatment for laser photocoagulation versus laser photocoagulation alone at 2 months, 4 months and 9 months after initiation of treatment study. Evaluate the tolerance of intravitreous injections of bevacizumab. ;Primary end point(s): Proportion of patients with improvement of at least one stage of the disease according to the Schields classification (Am J Ophthalmol, 2001), 6 months after initiation of study treatment.;Timepoint(s) of evaluation of this end point: 6 months after initiation of study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Comparison, between the 2 groups, of the proportion of patients having an improvement of at least one stage of the Shields classification evaluated with retinal multimodal imaging by two independent experts at 2 months, 4 months and 9 months after initiation of study treatment. -Comparison between the 2 groups of each of the items defining the Shields stage at 2, 4, 6 and 9 months after the initiation of the study treatment: presence of telangiectasia, presence of exudates, presence of a retinal detachment; glaucoma, bulbous phtyse. -Comparison between the 2 groups of visual acuity (expressed in logmar) 4, 6 and 9 months after the initiation of the study treatment, in children of verbal age (from 3 years). -Comparison between the 2 groups of the variation of macular thickness (in micrometer), the presence of a serous uplift and the maximal thickness of fibrosis observed with optical coherence tomography at 2, 4, 6 and 9 months after the initiation of the study treatment for the children in whom it was made. -Comparison between the 2 groups of the number of patients for whom a complementary treatment (ie additional laser session - beyond the 3rd session - or surgical treatment) was necessary 9 months after the initiation of the study treatment. -Comparison between the 2 groups of the number of events and adverse effects (ie: passage to stage 5 (phtyse), need for surgical treatment, cataract, vitreoretinal fibrosis, detachment of functional retina as well as any serious adverse event detected by the investigator leading to discontinuation of treatment). ;Timepoint(s) of evaluation of this end point: 2, 4, 6 and 9 months after initiation of study treatment. | — |
Countries
France
Contacts
Public ContactUnité de Recherche Clinique
Fondation Adolphe de Rothschild
Outcome results
None listed