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RECRUITING
NCT04292080
PHASE2

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

55 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2022-02-07

Completion Date

2029-04-07

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Dimethyl Fumarate (TECFIDERA™)

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.

OTHER

No active : no treatment

Patients will receive no specific treatment (standard of care) up to 24 months following randomization.

Locations (1)

Centre intercommunal de Créteil

Créteil, Val De Marne, France