Macular degeneration Trials in Disease

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

This clinical trial is being conducted in France and focuses on geographic atrophy, which is a severe form of age-related macular degeneration. Geographic atrophy occurs when certain layers of the retina gradually deteriorate, leading to patches of vision loss in the central field of vision.

Main inclusion criteria:

• Participants must be between 55 and 85 years old
• Must have geographic atrophy in at least one eye, with the affected area measuring between 0.75 and 8 disk areas
• Vision in the affected eye must be between 20/20 and 20/200 (where 20/20 is perfect vision and 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 scan within 3 months before starting treatment
• The affected eye must be clear enough for good quality photographs to be taken
• Must have normal heart rhythm measurements
• Male participants with partners who can become pregnant must use contraception during the study and for four months after treatment ends
• Must have social security coverage

Main exclusion criteria:

• Age below 18 or above 85 years
• Any form of wet macular degeneration (where abnormal blood vessels grow under the retina)
• Previous treatment with Dimethyl Fumarate within the past 6 months
• Active eye infection or inflammation
• Significant liver or kidney disease
• Pregnancy or breastfeeding
• Recent participation in another clinical trial (within 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

Focus and goal of the trial:

The main purpose of this study is to determine whether Dimethyl Fumarate can slow down the growth of areas affected by geographic atrophy compared to standard care. The medication is thought to work by reducing inflammation and protecting cells in the retina. Throughout the study, participants will have their eyes examined using special imaging techniques called Fundus Auto-fluorescence, which allow doctors to measure the affected areas of the retina precisely.

The study lasts approximately one year. Participants will start with a lower dose of 120 mg twice daily for the first week, then increase to 240 mg twice daily for the remainder of the treatment period. Regular eye examinations and safety monitoring will be conducted throughout the study to track any changes in vision and ensure participant safety.

Investigational drug:

The trial is investigating Dimethyl Fumarate, an oral medication taken in capsule form that is specially coated to protect the stomach. This medication belongs to a class of compounds called fumaric acid esters. It works by activating antioxidant pathways and reducing inflammation in retinal cells, which may help slow the deterioration of vision in patients with geographic atrophy.

Unlike many other treatments for eye conditions that require injections directly into the eye, Dimethyl Fumarate is taken as a pill, making it easier and more convenient for patients to use. The medication is being compared to standard care to evaluate whether it provides better results for patients with this advanced form of dry macular degeneration.