Not recruitingRare disease

Study Comparing Aflibercept and Placebo for Patients with Macular Telangiectasia Type 1

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called macular telangiectasia type 1, which affects the eyes. In this condition, there are changes in the blood vessels in the macula, a part of the eye that is important for clear vision. The study is testing a treatment called aflibercept, which is a medication given as an injection into the eye. Aflibercept is designed to help reduce swelling in the macula and improve vision. Some participants in the study will receive aflibercept, while others will receive a placebo, which is a substance with no active medication.

The purpose of the study is to compare the effects of aflibercept with a placebo in patients with macular telangiectasia type 1. The study will observe changes in the thickness of the retina, which is the light-sensitive layer at the back of the eye, over a period of six months. Participants will have regular check-ups and eye examinations to monitor their condition and the effects of the treatment.

Throughout the study, the safety of the treatment will be closely monitored, including any changes in eye pressure or other eye-related issues. The study aims to provide valuable information on whether aflibercept can be an effective treatment for macular telangiectasia type 1, potentially leading to better management of this eye condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a comprehensive eye examination.
Eligibility criteria include having macular telangiectasia type 1, macular edema more than 320 micrometers, and specific visual acuity levels.
Step 2
Randomization
Participants are randomly assigned to receive either the aflibercept treatment or a placebo. This process ensures that the study results are unbiased.
Step 3
Treatment administration
The treatment involves the administration of aflibercept or placebo through an injection into the eye. The product used is Eylea 40 mg/mL solution for injection.
The injection is given intravitreally, meaning it is administered directly into the eye's vitreous cavity.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor the condition and response to treatment. These visits include eye examinations and imaging tests such as SD-OCT and OCTA.
The primary goal is to observe changes in central retinal thickness over a period of six months.
Step 5
Final assessment
At the end of the six-month period, a final assessment is conducted to evaluate the outcomes of the treatment.
This includes measuring changes in visual acuity, retinal volume, and capillary density, as well as checking for any ocular safety concerns.

Who can join the trial?

12 criteria

Patient who has given their written informed consent.
Patient is an adult.
Patient with **idiopathic macular telangiectasia type 1**, a condition affecting the eye, identified at least 4 months ago, with or without additional eye issues.
Patient with **macular edema**, which is swelling in the eye, more than 320 micrometers, confirmed by a special eye scan called SD-OCT.
Patient with **best-corrected ETDRS visual acuity** between strictly 24 and 79 letters, which is a way to measure vision clarity.
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Patient meeting at least one of the following criteria:
- Patient has not received any treatment before.
- Patient cannot have laser photocoagulation, a type of eye treatment.
- Patient still has macular edema after treatment with anti-VEGF, a type of medication, given more than 4 months ago.
- Patient still has macular edema after laser photocoagulation treatment more than 4 months ago.
- Patient still has macular edema after treatment with corticosteroids, a type of medication, given more than 6 months ago.
- Patient's eye doctor believes that delaying focal coagulation and anti-VEGF treatment for 6 months is safe.
- Woman of childbearing potential must agree to use an effective method of birth control during the trial and for at least 3 months after the last treatment.

Who cannot join the trial?

7 criteria

Patients with any other eye disease that could affect the study results.
Patients who have had eye surgery in the last 3 months.
Patients who are currently participating in another clinical trial.
Patients with uncontrolled high blood pressure.
Patients with a history of severe allergic reactions to medications.
Patients who are pregnant or breastfeeding.
Patients with any serious health condition that could interfere with the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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CHU Grenoble Alpes
La Tronche, France
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Centre Hospitalier Intercommunal Creteil
Creteil, France
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Centre Hospitalier Lyon Sud
Pierre Benite, France

Trial locations

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Investigated drugs

Aflibercept is a medication used in this clinical trial to treat patients with macular edema due to Macular Telangiectasia Type 1. It works by blocking the growth of abnormal blood vessels in the eye and reducing fluid leakage, which can help improve vision or prevent further vision loss.

Aflibercept

What is already known about the treatment

Aflibercept – Aflibercept is administered as an injection directly into the eye. It is currently being studied in clinical trials for its effectiveness in treating macular telangiectasia type 1, a condition affecting the retina. The main therapeutic indication for aflibercept in this trial is to reduce macular edema, which is swelling in the central part of the retina. At the molecular level, aflibercept works by inhibiting vascular endothelial growth factor (VEGF), which plays a role in the formation of abnormal blood vessels and leakage. It is classified as an anti-VEGF agent, commonly used in ophthalmology to treat various retinal diseases.

Investigated diseases

Macular Telangiectasia Type 1 – This is a rare eye condition characterized by abnormal blood vessels in the macula, the central part of the retina responsible for detailed vision. The disease leads to changes in the retinal structure, often resulting in macular edema, which is a swelling caused by fluid accumulation. Over time, these changes can affect central vision, making it difficult to perform tasks that require sharp vision, such as reading or recognizing faces. The progression of the disease involves the thickening of the central retina and alterations in the capillary network around the fovea. These changes can be monitored using imaging techniques like optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA).