Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia … (NCT03845049) | Clinical Trial Compass
TerminatedPhase 3
Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
Stopped: very rare disease, many difficulties in recruiting patients, inclusion rate far too slow, making it impossible to meet the main objective within a reasonable timeframe. the sponsor therefore decided to stop the study.
France16 participantsStarted 2019-07-03
Plain-language 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 tortuosity of the macular capillary network on the temporal part of the fovea that can be identified on fundus examination. It can be associated with peripheral vascular changes, similar to manifestations of Coats' disease. It can be complicated by macular edema due to leakage from microvascular ectasia. When associated with visual loss, macular edema can be treated with different strategies although there is no consensus about the best approach. Laser can be performed on leaky aneurysms with questionable long term efficacy and potential irreversible adverse effects. Recently, anti-VEGF agents have been put forward as particularly good candidates to treat this macular edema, as observed in vein occlusion or diabetic macular edema. Indeed, in limited case series, the first anti-VEGF agents (ranibizumab and bevacizumab) showed mitigated results. More recently, authors have reported some favorable results with aflibercept in patients refractory to other anti-VEGF agents. Indeed a recent study reported both good anatomical and functional results in macular edema due to Mac Tel 1 in a non-comparative study that included 8 patients and carried out a concomitant quantification of growth factors. As an explanation, the authors found that levels of placental growth factor (PlGF), which is targeted by aflibercept but not by other anti-VEGF agents, were decreased after treatment. Moreover, PlGF correlated with capillary plexus densities assessed by OCTA. The aim of this study is thus to assess the efficacy of a 6 months treatment by aflibercept compared to placebo in macular edema linked to Mac Tel 1 with a multicenter double-blind randomized clinical trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Pati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.