Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1 (TELeMAC)

This is an interventional treatment trial for Macular Telangiectasia Read More

Inclusion Criteria:

• 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 with a contraindication for laser photocoagulation or with persistence of macular edema after treatment with intravitreal bevacizumab, ranibizumab and/or laser photocoagulation administered 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 Criteria:

• 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 treated with aflibercept in the last 4 months before inclusion
• Patient presenting any cardiovascular eventwithin 6 months before inclusion
• Poor media clarity, which can prevent adequate fundus imaging
• Patient having prior focal photocoagulation within the previous 4 months
• 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).