Actively Recruiting
Long-Term Analysis of Dimethyl Fumarate to Slow Growth of Geographic Atrophy in Age-Related Macular Degeneration
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-04
90
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Age-related Macular Degeneration (AMD) is a leading cause of irreversible blindness, with the dry form known as geographic atrophy (GA) affecting about 80% of patients. GA involves progressive loss of essential cells in the eye, leading to vision loss. This trial is a phase 2 study that aims to assess the safety, tolerability, and activity of a 12-month oral treatment with Dimethyl Fumarate (TECFIDERA4) for patients with GA associated with AMD. Participants in this randomized, open-label trial will be assigned to one of two groups: one group will receive oral Dimethyl Fumarate starting with 120 mg twice daily for one week, then increasing to 240 mg twice daily for 51 weeks, following the approved treatment scheme. The other group will receive no specific treatment but will continue with standard care for up to 24 months following randomization. Throughout the study, participants will undergo regular evaluations including fundus autofluorescence imaging to measure changes in GA lesion areas over 12 months. Safety and adverse events will be monitored for up to 24 months. Other assessments include visual acuity checks and brain MRI for certain participants. The study will track the progression of GA and the effects of the treatment over the study period.
CONDITIONS
Brief Title
Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 55 and 85 years at time of inclusion
- Ability to understand and sign the informed consent
- Presence of central or non-central geographic atrophy in at least one eye with lesion size between 0.75 and 8 disk areas
- Steady fixation in the study eye with clear media for quality photographs
- Visual acuity in affected eye between 20/20 and 20/200
- No signs of progressive multifocal leukoencephalopathy on brain MRI within 3 months before starting treatment (for treated group)
- Male participants with fertile female partners must use contraception during and for 4 months after treatment
- No history of heart disease, normal QTc duration (<480 ms)
- Affiliated with a social security scheme
You will not qualify if you...
- Participation in another interventional study within 3 months before inclusion
- Inability to comply with study procedures or follow-up
- Presence of ocular diseases other than GA that may affect outcomes (e.g., glaucoma, diabetic retinopathy, uveitis, exudative AMD)
- History of neo-vascular AMD
- Prior treatments for exudative AMD in study eye within 4 months
- Previous vitrectomy in study eye
- Expected need for ocular surgery during trial
- Recent lens removal or YAG laser capsulotomy
- Current chemotherapy or chronic immunosuppressive treatment
- Use of ocular or systemic medications toxic to eye structures
- History of malignancy compromising 2-year survival
- History of ocular herpes simplex virus
- Allergy or contraindication to Dimethyl Fumarate or excipients
- Severe active gastrointestinal disease
- Contraindications to MRI with gadolinium
- Contraindications to aspirin
- Significant abnormal lab values or lymphopenia
- Severe liver or kidney impairment
- Previous organ transplant
- Use of non-authorized medications prior to enrollment
- Any medical condition judged unsuitable by investigator
- Recent cancer diagnosis with risk from immunosuppression
- Ocular or peri-ocular inflammation or infection
- Active or latent tuberculosis
- Female participants of childbearing potential unless postmenopausal or sterilized
- Persons under legal guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive oral Dimethyl Fumarate (Tecfidera™) or no treatment as per their group assignment to evaluate safety and efficacy in slowing progression of geographic atrophy.
Regular visits during treatment period (exact number not specified)
Duration - Up to 12 additional months after treatment
Participants are monitored for safety and long-term effects up to 24 months after randomization.
Visits during follow-up period (exact number not specified)
Trial Site Locations
Total: 1 location
1
Centre intercommunal de Créteil
Créteil, Val De Marne, France, 94000
Actively Recruiting
Research Team
E
Eric SOUIED, PU-PH
S
Serge Camelo, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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