Recruiting

Study of dimethyl fumarate to slow the progression of geographic atrophy in patients with age-related macular degeneration (dry form)

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on Geographic Atrophy, a severe form of age-related Macular Degeneration that causes vision loss. This eye condition occurs when certain layers of the retina gradually deteriorate, leading to areas of vision loss in the central field of vision. The study will evaluate a medication called Dimethyl Fumarate, which will be given as oral capsules that are specially coated to protect the stomach.

The purpose of this research is to determine if Dimethyl Fumarate can slow down the growth of areas affected by Geographic Atrophy compared to standard care. The medication will be taken twice daily - starting with a lower dose of 120 mg twice daily for the first week, then increasing to 240 mg twice daily for the remainder of the study period, which lasts about one year.

Throughout the study, participants will have their eyes examined using special imaging techniques called Fundus Auto-fluorescence that allow doctors to measure the affected areas of the retina. The study will also include other eye examinations and safety monitoring. Some participants will undergo MRI scans of the brain before starting treatment to ensure their safety during the study.

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 treatment period - Week 1
You will receive dimethyl fumarate oral medication at a dose of 120mg twice daily
This initial dosing period lasts for the first week of treatment
Step 2
Main treatment period - Weeks 2-52
Starting from week 2, the dose increases to 240mg of dimethyl fumarate taken twice daily
This treatment continues for 51 weeks
Regular eye examinations will track changes in the affected area of your retina using special photographs
Step 3
Eye monitoring - Month 12
At the 12-month mark, detailed photographs of your eyes will be taken
These images will be used to measure changes in the affected area of your retina
The photographs will be taken using a special camera called Fundus Auto-fluorescence (FAF)
Step 4
Safety requirements throughout the study
Your vision must remain between 20/20 and 20/200 in the affected eye
Male participants with partners who can become pregnant must use contraception (condom) during the study and for four months after the last treatment
Regular monitoring of your heart rhythm will be conducted to ensure QTc measurements remain normal (below 480ms)
Step 5
Study completion
The study is scheduled to end in October 2027
Final evaluations will compare the changes in your eye condition from the beginning to the end of the treatment period

Who can join the trial?

9 criteria

Must be between 55 and 85 years old when joining the study
Must be able to understand and sign the study consent form
Must have geographic atrophy (an advanced form of dry macular degeneration) in at least one eye, with a size between 0.75 and 8 disk areas (a measurement doctors use to describe the affected area in the eye)
Must be able to focus steadily with the affected eye, and the eye must be clear enough for good photographs
Must have vision between 20/20 and 20/200 in the affected eye (20/20 is perfect vision, 20/200 means you must be 20 feet from an object to see what others can see from 200 feet)
Must have a normal brain MRI within 3 months before starting treatment (only for patients receiving Dimethyl Fumarate)
Male participants with partners who can become pregnant must use contraception (condom) during the study and for four months after the last treatment
Must not have any history of heart disease or family history of sudden death, and must have normal heart rhythm measurements (QTc less than 480ms)
Must have social security coverage

Who cannot join the trial?

15 criteria

Age below 18 or above 85 years
Any form of wet macular degeneration (a condition where abnormal blood vessels grow under the retina)
Previous treatment with Dimethyl Fumarate within the past 6 months
Active eye infection or inflammation
History of severe allergic reactions to medications
Significant liver or kidney disease
Pregnancy or breastfeeding
Participation in another clinical trial within the past 30 days
Uncontrolled high blood pressure
History of stroke or heart attack within the past 6 months
Active cancer or ongoing cancer treatment
Severe retinal diseases other than dry macular degeneration
Unable to provide informed consent
History of non-compliance with medical treatments
Unable to take oral medications

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
Centre Hospitalier Intercommunal Creteil
Creteil, France
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France
Verified
Centre Hospitalier Universitaire De Dijon
Dijon, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Dimethyl Fumarate is an oral medication taken twice daily that is being studied for treating geographic atrophy, which is a condition that occurs in the dry form of age-related macular degeneration (AMD). This medication is thought to help slow down the growth of areas in the eye affected by geographic atrophy. It works by reducing inflammation and protecting cells in the retina. The medication is taken as a pill, making it easier for patients to use compared to eye injections that are common in other AMD treatments. Standard of care (current typical treatment) is being used as a comparison in this study to determine if Dimethyl Fumarate provides better results for patients with geographic atrophy.

Dimethyl Fumarate

What is already known about the treatment

Dimethyl Fumarate - An oral medication administered in tablet form, taken twice daily, that has shown promise in treating geographic atrophy, a severe form of dry age-related macular degeneration (AMD). This compound belongs to the class of fumaric acid esters and works by activating antioxidant pathways and reducing inflammation in retinal cells. The medication is being studied for its potential to slow down the growth of areas affected by geographic atrophy in the retina, with initial dosing at 120mg twice daily for the first week, followed by 240mg twice daily for maintenance therapy. Currently undergoing clinical trials to evaluate its effectiveness in treating macular degeneration, where it represents a potential new therapeutic approach for a condition that has limited treatment options.

Investigated diseases

Macular degeneration – A progressive eye condition that affects the central part of the retina called the macula. The condition typically develops as a person ages, gradually destroying sharp, central vision needed for seeing objects clearly and for common daily tasks. In the dry form of the disease, light-sensitive cells in the macula slowly break down, causing blurred or reduced central vision. Geographic atrophy is an advanced form of dry macular degeneration where patches of retinal cells waste away and die. The condition usually affects both eyes, although vision loss may occur in one eye before the other.