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

Age-related Macular Degeneration (AMD) Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

Age-related Macular Degeneration (AMD) is the leading cause of irreversible blindness in the industrialized world. Approximately 80% of patients with AMD suffer from the dry form of the disease also called geographic atrophy (GA) which is characterized by the progressive loss of photoreceptors and RPE that are essential to the visual cycle. There is currently no therapy to cure GA. This represent a major health problem with millions patients worldwide.

GA is a complex multifactorial disease influenced by: aging, environmental factors, genetic predispositions, oxidative stress and inflammation. Oxidative stress is the major environmental risk factor of developing AMD. Whereas inflammation, is now, recognized as one of the main player in AMD pathophysiology. Therefore, antioxidant and immunosuppressive therapies are susceptible to be beneficial in humans for patients with GA.

Dimethyl Fumarate activates the NRF2 pathway, which is the major transcription factor regulating anti-oxidative enzymes production. Dimethyl Fumarate commercialized under the name TECFIDERA® by BIOGEN is an effective antioxidant and immunosuppressive drug, used to treat patients with Multiple Sclerosis (MS), an autoimmune disease of the Central Nervous System leading to progressive disability. This new therapeutic agent may be easily repurposed to treat GA patients and could reduce or slow photoreceptors and RPE degeneration and the associated vision loss.

In this randomized, open labelled trial we will evaluate the safety and efficacy of TECFIDERA®, in two groups of patients (treated vs. untreated) with GA. This is the first time this strategy, based on evidences that oxidative stress and inflammation are central in GA physiopathology, will be tested in patients with dry AMD. ;

Related Conditions & MeSH terms

• Age-related Macular Degeneration (AMD)
• Atrophy
• Geographic Atrophy
• Macular Degeneration

• NCT number: NCT04292080
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Eric SOUIED, PU-PH
• Phone: +33 1 45 17 59 08
• Email: eric.souied@chicreteil.fr
• Status: Recruiting
• Phase: Phase 2
• Start date: February 7, 2022
• Completion date: October 2026