RecruitingPhase 2NCT04292080

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

90 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study (LADIGA) is testing dimethyl fumarate (Tecfidera) — a drug approved for multiple sclerosis — to see if it can slow the growth of geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD) that causes progressive central vision loss. There is currently no approved treatment to halt GA. Dimethyl fumarate has anti-inflammatory and cell-protective properties that researchers believe may preserve retinal cells. You may be eligible if: - You are between 55 and 85 years old - You have central or non-central geographic atrophy in at least one eye, measuring between 0.75 and 8 disk areas - Your study eye has visual acuity between 20/20 and 20/200 - You have steady fixation in the foveal or parafoveal area and clear enough media for good photos - No signs of progressive multifocal leukoencephalopathy on brain MRI (for those in the Tecfidera group) - Male participants with partners of childbearing potential must use contraception - Normal ECG and no documented history of heart disease You may NOT be eligible if: - You have other significant eye diseases (glaucoma, diabetic retinopathy with 10+ bleeds, uveitis, exudative AMD, or moderate/severe myopia) - You have had prior anti-VEGF injections, laser, or photodynamic therapy in the study eye in the past 4 months - You are immunosuppressed or on chronic immunosuppressive medications - You have had cancer (other than non-melanoma skin cancer) within the past 5 years - You are a woman of childbearing age (not post-menopausal or surgically sterile) - You have severe gastrointestinal disease, contraindications to MRI with gadolinium, or severe kidney/liver impairment - You have active or latent tuberculosis or active toxoplasmosis in either eye Talk to your retinal specialist about this study if you have been diagnosed with geographic atrophy and are looking for potential treatments to slow vision loss.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDimethyl 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.

OTHERNo 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

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NCT04292080


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