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

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What is this study about?

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.

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

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

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)

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)

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Retina Saint-Cyr-Sur-Loire France
Theorie Etudes Organisation Recherche En Retine Medicale S.A.R.L. Paris France
Centre Monticelli Paradis D Ophtalmologie Marseille France
Fondation A De Rothschild Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Cegzcjte Mfdtbbuv Rouen France
Caioni Hnrbzvaalcv Uuhznnhhbupjf Dm Doslm Dijon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
07.02.2022

Trial locations

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.

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.

Trial ID:
2024-510741-33-00
Protocol code:
P170919
NCT ID:
NCT04292080
Trial Phase:
Therapeutic exploratory (Phase II)

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