Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy

Recruiting now · Phase 2

Conditions studied: Age-related Macular Degeneration (AMD)

In brief

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).

Key facts

Study ID: NCT04292080
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 90
Starts: 2022-02-07
Expected to finish: 2029-04-07
Last updated by the study team: 2026-02-04

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Centre intercommunal de Créteil — Créteil, Val De Marne, France (enrolling)

Full record on ClinicalTrials.gov

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