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
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
Treatments tested in this trial
- Dimethyl Fumarate (TECFIDERA™)
- No active : no treatment
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov