Comparing Aflibercept to Placebo for Macular Telangiectasia Type 1
Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
This study is testing whether a medication called Aflibercept can help people with macular telangiectasia type 1 improve their vision and reduce swelling in their eyes compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | ranibizumab, bevacizumab |
| Locations | 1 site (Dijon) |
| Trial ID | NCT03845049 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of Aflibercept, an anti-VEGF agent, compared to a placebo in treating macular edema associated with idiopathic macular telangiectasia type 1. The study involves monthly examinations and injections over a specified period to assess visual acuity and changes in macular edema. Patients eligible for the trial must have been diagnosed with the condition at least four months prior and exhibit specific visual acuity and edema measurements. The goal is to determine if Aflibercept can provide a more effective treatment option than current methods.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with idiopathic macular telangiectasia type 1 who have persistent macular edema.
Not a fit: Patients who have already undergone multiple treatments without success or those with contraindications to anti-VEGF therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve visual outcomes for patients suffering from macular telangiectasia type 1.
How similar studies have performed: Previous studies have shown promise with anti-VEGF agents in treating similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Dijon
- CHU dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Catherine CREUZOT GARCHER
- Email: catherine.creuzot-garcher@chu-dijon.fr
- Phone: +33 3 80 29 51 73
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.