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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age55-85

SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Dimethyl Fumarate (TECFIDERA™)
Drug
Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13, containing 120 mg or 240 mg of dimethyl fumarate The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Body weight, gender, and age do not require dosage adjustment.
No active : no treatment
Other intervention
Patients will receive no specific treatment (standard of care) up to 24 months following randomization.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Group TECFIDERA™Experimental treatment 1 intervention

Group B: No comparatorOther 1 intervention

Trial outcomes

Primary outcomes

Change From Baseline to Month 12 in total area of GA Lesion(s) in the study eye (in mm2) as Measured by Fundus Autofluorescence (FAF)

Time frame

12 Months

Secondary outcomes

Incidence and severity of ocular and systemic treatment-related adverse events as assessed by CTCAE v4.0".

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

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