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Study on Elamipretide for Patients with Dry Age-Related Macular Degeneration (Dry AMD)

Verified siteInvestigational

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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 Dry Age-Related Macular Degeneration (Dry AMD), a common eye condition that can lead to vision loss in older adults. The trial will evaluate a treatment called Elamipretide, which is administered as a solution for injection under the skin. The purpose of the study is to assess the effectiveness and safety of this treatment in individuals with Dry AMD.

Participants in the trial will receive daily injections of either Elamipretide or a placebo, which looks like the treatment but does not contain the active ingredient. The study will monitor changes in the eye over time, specifically looking at the area of the eye affected by the disease. This will help determine if Elamipretide can slow down or improve the condition.

The trial will last for a period of time, with regular check-ups to assess the health of the participants' eyes. The study aims to provide valuable information on whether Elamipretide can be a beneficial treatment option for those suffering from Dry Age-Related Macular Degeneration.

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
Joining the study
Upon joining the study, eligibility is confirmed. Participants must be adults aged 55 or older with dry age-related macular degeneration (AMD) in at least one eye. This is determined by the presence of photoreceptor loss.
Participants must agree to use effective birth control methods if applicable and be able to administer the investigational medication.
Step 2
Initial assessment
An initial assessment is conducted to establish a baseline for the study. This includes a detailed examination of the eyes using specialized imaging techniques to measure the area of photoreceptor loss.
Step 3
Medication administration
Participants receive a daily subcutaneous injection of elamipretide or a placebo. The injection is administered under the skin.
The medication is provided in the form of a solution for injection.
Step 4
Ongoing assessments
Regular assessments are conducted to monitor changes in the macular area of photoreceptor loss. These assessments occur at specified intervals, including weeks 48, 72, and 96.
The assessments involve imaging techniques to map changes in the eye and measure visual acuity improvements.
Step 5
Completion of the study
The study is expected to conclude by December 28, 2027. At the end of the study, a final assessment is conducted to evaluate the overall efficacy and safety of the treatment.

Who can join the trial?

7 criteria

Must be an adult aged 55 years or older.
Must have at least one eye with **dry age-related macular degeneration (Dry AMD)**, which is a condition affecting the eye, with loss of cells called photoreceptors. This will be checked during the Screening Visit.
Women who can have children must agree to use a reliable method of birth control.
Men with female partners who can have children must agree to use a highly effective method of contraception, such as abstinence or using two methods of birth control.
The affected area in the study eye can have more than one spot, as checked during the Screening Visit.
Must be able to give themselves the study medication.
Must be able to understand and agree to the study details, including attending all site visits, undergoing examinations, taking the study medication daily, keeping a dosing diary, and following other study requirements.

Who cannot join the trial?

7 criteria

Patients who have 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 using any other treatment for Dry Age-Related Macular Degeneration (Dry AMD).
Patients with a history of severe allergic reactions to medications.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial in the last 30 days.
Patients with any serious health condition that the study doctor thinks 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

ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Axon Clinical s.r.o.
Verified
Prague, Czechia
Azienda Sanitaria Universitaria Friuli Centrale
Verified
Udine, Italy

Trial locations

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Investigated drugs

Elamipretide is a medication being studied for its potential to help people with dry age-related macular degeneration (AMD). It is given as a subcutaneous injection, which means it is injected under the skin. The goal of using elamipretide in this trial is to see if it can improve the condition of the eyes in people with dry AMD, making it a possible treatment option for this eye disease.

Elamipretide Trihydrochloride

What is already known about the treatment

Elamipretide – Elamipretide is administered through subcutaneous injections, meaning it is injected under the skin. It is currently being studied in clinical trials for its potential use in treating Dry Age-Related Macular Degeneration (Dry AMD). The main therapeutic indication for Elamipretide is to improve the condition of patients with Dry AMD by targeting mitochondrial dysfunction. At the molecular level, Elamipretide works by penetrating cell membranes and enhancing the function of mitochondria, which are the energy-producing structures within cells. It is classified pharmacologically as a mitochondrial-targeting peptide.

Investigated diseases

Dry Age-Related Macular Degeneration (Dry AMD) – This is a common eye condition that affects the macula, the part of the retina responsible for clear central vision. It occurs when the macula thins with age, leading to a gradual loss of central vision. People with dry AMD may notice blurred vision or difficulty recognizing faces. The disease progresses slowly and can affect one or both eyes. Over time, it can lead to a significant decrease in the ability to see fine details. However, it does not typically cause complete blindness, as peripheral vision remains intact.