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

Inclusion Criteria:

• Patient who have given their written informed consent

• Patient major

• Patient with idiopathic macular telangiectasia type 1 identified at least 4 monthspreviously, with or without peripheral exudative abnormalities

• Patient with macular edema more than 320 μm confirmed by a blind review of SD-OCTimages

• 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 (includingaflibercept) administered more than 4 months previously

• Patient with persistence of macular edema after laser photocoagulation treatmentmore than 4 months previously

• Patient with persistence of macular edema after treatment with corticosteroidsadministered 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 safelydeferred for 6 months

• Woman of childbearing potential (WOCBP)* must commit to consider and use anefficient method of birth control during the trial and at least 3 months after thelast 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 (namelyretinal vein occlusion, diabetic retinopathy, ocular ischemic syndrome, sickle-cellanemia, 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 theexcipients of EYLEA®

• Patient with active or suspected ocular or periocular infection or severe activeintraocular inflammation.

• Any history of allergy to the antiseptic used during preparation of the eye for theIVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).