Evaluating PRIMA Device to Restore Central Vision in Adults with Inherited Retinal Degeneration

What this Trial Is About

Researchers are evaluating the PRIMA Products to restore limited central vision in people with inherited retinal degeneration affecting the macula, such as Stargardt disease and Retinitis Pigmentosa. This study aims to assess the safety and effectiveness of the PRIMA implant in improving visual function for those who have lost central vision due to photoreceptor cell degeneration. The study is sponsored by Science Corporation Australia and builds on prior successful testing in patients with geographic atrophy. Participants will receive the PRIMA Stim implant designed to stimulate the retina where photoreceptors have degenerated. After implantation, participants will undergo vision training and regular follow-up visits to monitor progress. The study includes assessments at multiple time points over up to 36 months to track changes in visual acuity, reading ability, and any procedure- or device-related adverse events. During the study, participants will complete various visual function tests and functional vision evaluations at scheduled intervals. Researchers will measure the proportion of participants showing improvement in visual acuity at 6, 12, 24, and 36 months, as well as track the severity of any side effects. Participants must commit to attending all follow-up visits and will be monitored closely to collect data supporting continued development and evaluation of the PRIMA Products.

Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration