Actively Recruiting
Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-04
90
Participants Needed
1
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objectives of the study are to assess the safety, tolerability and evidence of activity of 12 months oral treatment with TEFIDERA® in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).
CONDITIONS
Official 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 55 to 85 years at time of inclusion
- Able to understand and sign the informed consent document
- Have central or non-central geographic atrophy in at least one eye, sized between 0.75 and 8 disk areas
- Have steady fixation in the study eye and clear media for good quality photographs
- Visual acuity between 20/20 and 20/200 in the affected eye
- No signs of progressive multifocal leukoencephalopathy on brain MRI within 3 months of treatment start (TECFIDERA group only)
- Male participants with female partners capable of conceiving must use contraception during and 4 months after treatment
- No history of heart disease or family history of sudden death; normal QTc duration (<480ms)
- Affiliated to a social security scheme
You will not qualify if you...
- Participation in another interventional study within 3 months before inclusion
- Unable to comply with study procedures or follow-up visits
- Presence of ocular diseases other than GA that may affect study outcomes
- History of neo-vascular AMD
- Received treatment for exudative AMD in the study eye within last 4 months
- History of vitrectomy in the study eye
- Expected need for ocular surgery during the trial
- Lens removal in last 3 months or YAG laser capsulotomy in last month
- Current chemotherapy treatment
- Use of chronic immunosuppressive medication or immunosuppressed state
- Use of medications toxic to lens, retina or optic nerve
- History of malignancy compromising 2-year survival
- History of ocular herpes simplex virus
- Contraindications or allergy to Dimethyl Fumarate or excipients
- Severe active gastrointestinal disease
- Contraindications to MRI with gadolinium
- Contraindications to aspirin
- Abnormal lab values or lymphopenia
- Severe impairment of vital organs
- Previous organ transplant
- Use of non-authorized treatments or nephrotoxic drugs within 3 months prior to enrollment
- Unstable medical condition
- History of cancer within last 5 years that risks immunosuppression
- Ocular or peri-ocular inflammation or infection
- Active or latent toxoplasmosis
- Active or latent tuberculosis infection
- Female participants of childbearing potential (unless postmenopausal or surgically sterile)
- Persons under curatorship or guardianship
AI-Screening
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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
CONTACT
S
Serge Camelo, PHD
CONTACT
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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