Eye drug trial for rare macular disease stops early – only 16 patients enrolled

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 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 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).