Active not recruitingPHASE3INTERVENTIONAL

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

This study, called ReNEW, is testing a new medicine called elamipretide for people living with dry Age-related Macular Degeneration (AMD). AMD is a common eye condition that can affect your central vision. The main goal is to find out if elamipretide can slow down the loss of light-sensing cells in the eye, which is a key part of AMD. We also want to understand how safe the medicine is and if people can tolerate daily injections. Half the participants will receive the active drug, and the other half will receive a dummy injection (placebo). This helps us see if any changes are truly due to the new medicine.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Stealth BioTherapeutics Inc.

Enrolment target

313

Start

30 May 2024

Estimated completion

01 Sep 2027

Age Related Macular Degeneration (ARMD)

What is this study about?

Age-related Macular Degeneration (AMD) is a common eye condition that mainly affects people over 50. It damages the macula, the central part of your retina that helps you see fine details and colours. This means that everyday tasks like reading, driving, and recognising faces can become difficult. There are two types: wet AMD and dry AMD. This study focuses on dry AMD, which is more common and unfortunately, there aren't many treatments available for it right now.

This study, called ReNEW, is looking at a new medicine called elamipretide. Researchers want to see if this medicine can help slow down the progression of dry AMD. Specifically, they're interested in whether it can reduce the loss of special light-sensing cells in the macula. If successful, this could mean a significant step forward in preserving vision for people with dry AMD.

The study also has two other important goals. Firstly, it wants to check the safety of elamipretide and make sure people can comfortably take the daily injections. Secondly, it will look at how the medicine moves through the body, which helps scientists understand how it works. By comparing people who receive the drug with those who receive a dummy injection (placebo), we can get a clear picture of elamipretide's effects.

Key takeaways

Tests a new medicine (elamipretide) for dry AMD.
Aims to slow down vision loss.
Involves daily injections for nearly two years.
Compares the drug to a dummy injection (placebo).
Checks both the effectiveness and safety of the new treatment.
Requires regular eye checks and visits to the clinic.

Who may be eligible?

To join this study, you need to be at least 55 years old and have dry Age-related Macular Degeneration (AMD) in at least one eye. The doctor will check your eyes to make sure the specific type of AMD you have matches what the study is looking for. For instance, the area of your eye affected by AMD needs to be of a certain size and location, not too close to the very center of your vision.

You'll also need to have good enough vision to take part in the vision tests during the study. Your eye doctor will perform several tests to ensure your eye is suitable. Your overall health needs to be good enough to participate, and you or a close family member or carer must be able to give the daily injections correctly.

Finally, you must be able to attend all the appointments, understand what the study involves, and agree to follow all the instructions. If you are a woman of childbearing potential, you will need to agree to use contraception during the study.

Quick self-check

Are you 55 years old or older?
Have you been diagnosed with dry AMD in at least one eye?
Can you or a family member/carer give daily injections?
Are you able to attend regular clinic appointments for about two years?
If you could have children, are you willing to use contraception during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups by chance, like flipping a coin. You'll either receive the study drug, elamipretide, or a dummy injection (placebo), neither you nor your doctor will know which one you are getting. Both are given as daily injections under the skin, similar to how some diabetes medications are given. These injections will continue for a period of 96 weeks, which is about 1 year and 10 months.

Throughout this time, you will have regular visits to the clinic where doctors will check your eyesight and take detailed pictures of your eyes. They will also monitor your general health to make sure you're doing well and that the treatment is safe for you. You'll need to keep a diary of your injections. The total duration of your participation, including follow-up, will be around two years.

Potential risks and benefits

Participating in research studies comes with potential benefits and risks. A potential benefit of taking part in this study is that you might receive access to a new treatment for dry AMD that isn't yet available. This treatment could potentially help slow down the progression of your condition. However, there's also a chance you might receive the placebo, which has no active drug. Potential risks might include discomfort or side effects from the injections, and the regular clinic visits could be time-consuming. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (53)

Associated Retina Consultants
Phoenix, United States
Barnet Dulaney Perkins Eye Center
Sun City, United States
Retina Associates of Southern California
Huntington Beach, United States
Retina Consultants of San Diego
Poway, United States
Retinal Consultants Medical Group
Sacramento, United States
Orange County Retinal Medical Group
Santa Ana, United States
Bay Area Retina Associates
Walnut Creek, United States
Retina Consultants of Southern Colorado
Colorado Springs, United States
Connecticut Eye Consultants, P.C.
Danbury, United States
Vitreo Retinal Associates
Gainesville, United States
Florida Retina Institute
Orlando, United States
Retina Vitreous Associates of Florida
St. Petersburg, United States

+41 more sites — see the official record for the full list.

Common questions

What is dry Age-related Macular Degeneration (AMD)?

It's a common eye condition that affects the central part of your vision, making tasks like reading difficult. It's called 'dry' because it doesn't involve leaky blood vessels like the 'wet' type.

What is elamipretide?

Elamipretide is the new medicine being tested. It's hoped that it might help slow down the loss of vision in people with dry AMD.

What is a placebo?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine.

How will I receive the treatment?

The treatment will be given as a daily injection under the skin, which you or a carer can learn to do at home.

How long will the study last?

You will receive treatment for about 1 year and 10 months, and the total study participation will be around two years.