In short
There is currently 1 ongoing clinical trial for macular telangiectasia, a rare eye condition that affects the blood vessels in the macula, the central part of the retina responsible for detailed vision. This trial is investigating aflibercept, a medication given as an injection into the eye, to determine whether it can reduce swelling and improve vision in patients with macular telangiectasia type 1.
Clinical trial locations
Study Comparing Aflibercept and Placebo for Patients with Macular Telangiectasia Type 1
This clinical trial is testing aflibercept, a medication administered as an injection into the eye, for patients with macular telangiectasia type 1. The condition affects the blood vessels in the macula, causing swelling and potentially affecting central vision. The study compares aflibercept to a placebo to determine if the medication can effectively reduce macular swelling and improve vision over a six-month period.
Main inclusion criteria:
- Adult patients who have given written informed consent
- Diagnosed with idiopathic macular telangiectasia type 1 for at least 4 months
- Macular edema measuring more than 320 micrometers, confirmed by SD-OCT imaging
- Best-corrected visual acuity between 24 and 79 letters on the ETDRS chart
- Either treatment-naive or have persistent macular edema after previous treatments such as laser photocoagulation, anti-VEGF medications, or corticosteroids
- Eye doctor confirms it is safe to delay other treatments for 6 months
- Women of childbearing potential must use effective contraception during the trial and for at least 3 months after the last treatment
Main exclusion criteria:
- Other eye diseases that could affect study results
- Eye surgery within the last 3 months
- Current participation in another clinical trial
- Uncontrolled high blood pressure
- History of severe allergic reactions to medications
- Pregnancy or breastfeeding
- Serious health conditions that could interfere with the study
Focus and goals:
The primary goal of this trial is to observe changes in the thickness of the central retina over six months. Participants undergo regular follow-up visits that include comprehensive eye examinations and specialized imaging tests such as SD-OCT and OCTA. These tests allow researchers to monitor changes in retinal thickness, volume, and capillary density. The study also carefully monitors safety aspects, including eye pressure and other potential eye-related complications. By comparing the effects of aflibercept with placebo, the trial aims to provide valuable information on whether this medication can effectively treat macular telangiectasia type 1.
Investigational drug:
The study uses aflibercept, marketed as Eylea 40 mg/mL solution for injection. Aflibercept is an anti-VEGF agent that works by blocking vascular endothelial growth factor, which plays a role in the formation of abnormal blood vessels and fluid leakage in the eye. The medication is administered intravitreally, meaning it is injected directly into the vitreous cavity of the eye. It is designed to reduce macular edema by preventing the growth of abnormal blood vessels and decreasing fluid accumulation, potentially improving or stabilizing vision.
Summary
Currently, there is only one ongoing clinical trial specifically for macular telangiectasia type 1, and it is being conducted in France. This trial focuses on evaluating aflibercept, an anti-VEGF medication, as a potential treatment for reducing macular edema and improving vision in affected patients. The trial is particularly important because macular telangiectasia type 1 is a rare condition with limited treatment options. The study includes patients who are treatment-naive as well as those who have not responded adequately to previous treatments, offering hope for a broader range of patients. The six-month observation period will provide valuable data on the medication's effectiveness and safety profile in this specific patient population.
