Can a common MS drug slow blindness in AMD?
NCT ID NCT04292080
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether an oral drug called dimethyl fumarate (Tecfidera) can safely slow the growth of geographic atrophy, a form of advanced age-related macular degeneration that causes vision loss. About 90 adults aged 55–85 with geographic atrophy will take the drug for 12 months. Researchers will measure changes in the size of the damaged area in the eye and track any side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Age 55 years of age to 85 years old at the moment of inclusion * Participant must understand and sign the protocol's informed consent document * Participant must have central or non-central geographic atrophy (GA) in at least one eye. GA should be at least 0.75 disk areas (DA) in size but no more than 8 disk areas (DA); approximately 2.54 mm2 is 1 DA. (GA is defined as one or more well-defined, usually more or less circular patches of partial or complete de-pigmentation of the retinal pigment epithelium (RPE), typically with exposure of underlying choroïdal blood vessels. Even if much of the RPE appears to be preserved and large choroïdal vessels are not visible, a round patch of RPE partial de-pigmentation may still be classified as early GA. If a patient has 2 eligible eyes; one eye will be the "study eye", graded and evaluated during the whole duration of the study) * Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs * Participant must have visual acuity between 20/20 and 20/200 in the affected eye * No suggestive sign of progressive multifocal leukoencephalopathy on brain MR Imaging within 3 months of Tecfidera© treatment Initiation (Only the patients randomized in the TECFIDERA Group will have to go through the MR Imaging) * Male participants with female partners capable of conceiving children will be required to use contraception (condom) during the study and for four months after their last experimental treatment caps * No documented history of heart disease, absence of family history of sudden death, and QTc duration within normal value (\<480ms) * Participants must be affiliated to a social security scheme Exclusion Criteria: * Participant is in another interventional investigational study \< 3 months before inclusion * Participant is unable to comply with study procedures or follow-up visits * Participant has evidence of ocular disease other than GA in either eye that may confound the outcome of the study (e.g., glaucoma, diabetic retinopathy with 10 or more hemorrhages or micro-aneurysms, uveitis, pseudo-vitelliform macular degeneration, exudative macular degeneration, moderate/severe myopia) * Participant with antecedent of neo-vascular AMD. * Participant has received treatment for exudative AMD, such as macular laser, photodynamic therapy (PDT) or anti-vascular endothelial growth factor (anti-VEGF) therapy intra-vitreal (IVT) injection or of any agent (e.g., triamcinolone) in the study eye within the last four months prior to study enrollment. Vitamin supplementation for AMD is not considered an exclusionary criterion * Participant has had a vitrectomy in the study eye * Participant is expected to need ocular surgery during the course of the trial * Participant has undergone lens removal in the last three months or Yttrium Aluminium Garnet (YAG) laser capsulotomy within the last month * Participant is on chemotherapy * Participant is on chronic (more than 3 months) immunosuppressive medication administered via ocular or systemic route(s) or is immunosuppressed * Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve * Participant with a history of malignancy that would compromise the 2-year study survival * Participant with a history of ocular herpes simplex virus (HSV) * Contra-indications or known hyper-sensibility to Dimethyl Fumarate (Tecfidera™) or experimental treatment excipients * Severe active gastrointestinal disease * Contra-indications to an MRI using gadolinium such as pace maker, cardiac valve non IRM compatible, cochlear implant or any metallic implant non IRM compatible. * Any contraindications to gadolinium including pregnancy, previous allergic reaction, severe kidney disease * Any contraindications to aspirin * Any screening laboratory value (hematology, serum chemistry or urinalysis) 3 times above normal values or that in the opinion of the Investigator is clinically significant and not suitable for study participation * Lymphopenia below normal laboratory values at inclusion. * Severe impairment of a vital organ including severe liver and renal impairment * Previous organ allograft * Patients taking the following non-authorized treatment 3 months prior enrolment: other fumaric acid derivatives (topical occular or systemic), immuno-modulators via ocular or systemic routes (including interferons, sirolimus, chronic use of glucocorticoids) cytotoxic treatments and live attenuated vaccines.(NB: During the experimental treatment period and 3 months thereafter the concomitant use of non-authorized treatment cited above is not allowed in patients randomized in the TEFIDERA group) * Patients taking the following non-authorized treatment 3 months prior enrolment: nephrotoxic treatment (aminoglycosides, diuretics, nonsteroidal anti-inflammatory drugs (via ocular or systemic routes) or lithium). (NB: During the experimental treatment period and 3 months thereafter the concomitant use of non-authorized nephrotoxic treatment cited above is not allowed in patients randomized in the TEFIDERA group) * Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control) * History of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years that could be worsened by immunosuppression (In case of history of cancer the risk of immunosuppression must be determined by a specific oncology consultation prior to enrollment.) * Ocular or peri-ocular inflammation or infection in either eye * Presence of active or inactive toxoplasmosis in any or both eye(s) * Presence of active or latent tuberculosis infection * Female participants of child bearing potential (those who are not post-menopausal or surgically sterile). Postmenopausal state is 12 months of amenorrhea + high level of FSH if required. * Persons under curatorship or guardianship
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre intercommunal de Créteil
RECRUITINGCréteil, Val De Marne, 94000, France
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