Study of Dimethyl Fumarate Tecfidera to Slow Geographic Atrophy in Age-Related Macular Degeneration Patients Aged 55 to 85

What this Trial Is About

Age-related Macular Degeneration AMD is a leading cause of irreversible blindness, with the dry form known as geographic atrophy GA affecting about 80% of patients. GA involves progressive loss of essential cells in the eye, leading to vision loss. This trial is a phase 2 study that aims to assess the safety, tolerability, and activity of a 12-month oral treatment with Dimethyl Fumarate TECFIDERA4 for patients with GA associated with AMD. Participants in this randomized, open-label trial will be assigned to one of two groups one group will receive oral Dimethyl Fumarate starting with 120 mg twice daily for one week, then increasing to 240 mg twice daily for 51 weeks, following the approved treatment scheme. The other group will receive no specific treatment but will continue with standard care for up to 24 months following randomization. Throughout the study, participants will undergo regular evaluations including fundus autofluorescence imaging to measure changes in GA lesion areas over 12 months. Safety and adverse events will be monitored for up to 24 months. Other assessments include visual acuity checks and brain MRI for certain participants. The study will track the progression of GA and the effects of the treatment over the study period.

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