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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Augenzentrum Am St Franziskus-Hospital Muenster	Munster	Germany
Centro De Oftalmologia Barraquer S.A.	Barcelona	Spain
Fundacion Aiken De La Comunitat Valenciana	Valencia	Spain
Oftalmologia Vistahermosa S.L.	Burjassot	Spain
Nozologen Kft.	Pecs	Hungary
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
University Of Szeged	Szeged	Hungary
Aaka Cblqbpob seepln	Prague	Czechia
Vfpwlb Oukvqcgygyhii Rfhtltkq Stuu	Sant Cugat Del Valles	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	30.08.2024
Germany	Not recruiting	30.08.2024
Hungary	Not recruiting	30.08.2024
Italy	Not recruiting	30.08.2024
Spain	Not recruiting	30.08.2024

Trial locations

Investigated drugs:

Elamipretide Trihydrochloride

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.

Investigated diseases:

Dry age-related macular degeneration

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.

Trial ID:

2024-511482-11-00

Protocol code:

SPIAM-301

NCT ID:

NCT06373731

Trial Phase:

Therapeutic confirmatory (Phase III)

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