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

Who is this study for? Patients with geographic atrophy associated with age-related macular degeneration
What treatments are being studied? Dimethyl Fumarate
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
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⁃ 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

Locations
Other Locations
France
Centre intercommunal de Créteil
RECRUITING
Créteil
Contact Information
Primary
Eric SOUIED, PU-PH
eric.souied@chicreteil.fr
+33 1 45 17 59 08
Backup
Serge Camelo, PHD
sergecamelo2@hotmail.com
Time Frame
Start Date: 2022-02-07
Estimated Completion Date: 2027-10-07
Participants
Target number of participants: 60
Treatments
Experimental: Group TECFIDERA™
30 patients will receive oral administration of Dimethyl Fumarate (Tecfidera™) 120 mg twice a day for the first week and then 240 mg of Tecfidera twice a day for 51 weeks following approved standard treatment scheme.
Other: No comparator
30 patients will receive no specific treatment (standard of care) up to 24 months following randomization.
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov