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Comparative multicenter randomized study of aflibercept versus placebo in macular telangiectasia type 1
EU CTIS ID: 2024-511885-35-00
What this study is testing
To compare the evolution of central retinal thickness between M0 and M6 in patients with macular edema due to Mac Tel 1 treated with aflibercept versus placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 strictly 24 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
You likely can't join if
- Patient not affiliated to a national health insurance scheme
- 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)
- Patient subject to a measure of legal protection (guardianship, tutorship)
- Patient subject to a court order
- Patient pregnant, parturient or nursing women (WOCBP)
See the full eligibility 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 strictly 24 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
- Patient not affiliated to a national health insurance scheme
- 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)
- 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 event within 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®
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.