Status:
RECRUITING
Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Macular Telangiectasia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Idiopathic juxtafoveal telangiectasia type 1 is a rare unilateral disease that mostly affects men before 50 years of age. Mac Tel 1 are characterized by microvascular telangiectasia and increased tort...
Eligibility Criteria
Inclusion
- Patient who have given their written informed consent
- Patient major
- Patient with idiopathic macular telangiectasia type 1 identified at least 4 months previously, with or without peripheral exudative abnormalities
- Patient with macular edema more than 320 μm confirmed by a blind review of SD-OCT images
- Patient with best-corrected ETDRS visual acuity between strictly24 and 79 letters
- Patient meeting at least 1 of the following criteria:
- Patient naive to any treatment
- Patient with a contraindication for laser photocoagulation
- Patient with persistence of macular edema after treatment with anti-VEGF (including aflibercept) administered more than 4 months previously
- Patient with persistence of macular edema after laser photocoagulation treatment more than 4 months previously
- Patient with persistence of macular edema after treatment with corticosteroids administered more than 6 months previously
- Patient with an assessment by the treating ophthalmologist that focal coagulation (for both groups) and anti-VEGF treatment (for the placebo group) could be safely deferred for 6 months
- Woman of childbearing potential (WOCBP)\* must commit to consider and use an efficient method of birth control during the trial and at least 3 months after the last aflibercept/SHAM administration
Exclusion
- Patient not affiliated to a national health insurance scheme
- Patient subject to a measure of legal protection (guardianship, tutorship)
- Patient subject to a court order
- Patient pregnant, parturient or nursing women (WOCBP)\*
- Patient incapable of expressing consent
- Patient with edema linked to conditions other than macular telangiectasia (namely retinal vein occlusion, diabetic retinopathy, ocular ischemic syndrome, sickle-cell anemia, maculopathy, hypertensive retinopathy…)
- Patient presenting any cardiovascular eventwithin 6 months before inclusion
- Poor media clarity, which can prevent adequate fundus imaging
- Patient with hypersensitivity to the active substance (aflibercept) or to any of the excipients of EYLEA®
- Patient with active or suspected ocular or periocular infection or severe active intraocular inflammation.
- Any history of allergy to the antiseptic used during preparation of the eye for the IVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03845049
Start Date
July 3 2019
End Date
December 1 2027
Last Update
July 29 2025
Active Locations (1)
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1
CHU dijon Bourgogne
Dijon, France, 21000