Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration
brief summary
The objective of this study is to evaluate the efficacy and safety of the PRIMA Products in participants with inherited retinal degeneration affecting the macula (including but not limited to Stargardt disease, and Retinitis Pigmentosa). Eligible participants will be implanted with the PRIMA Stim implant. The participants will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA Products. The purpose of this study is to gather enough clinical data to support the clinical evaluation required for the continuous development to improve the PRIMA Products.
detailed description
Science has developed the PRIMA Products, which are designed to restore limited visual perception in severely sight-impaired persons with a functional optic nerve and retinal ganglion cell layers who have lost their central vision due to the degeneration of photoreceptor cells.
The PRIMA Products have been tested successfully in 38 patients with Geographic Atrophy. PRIMA was found to be both safe and effective in this population. This exploratory study is to investigate whether patients with inherited retinal degeneration affecting the macula can also benefit from PRIMA.
The objective of this study is to evaluate the efficacy and safety of the PRIMA Products in participants with inherited retinal degeneration, affecting the macula and resulting in photoreceptor degeneration, including Stargardt disease and retinitis pigmentosa. The investigation is sponsored by Science Corporation Australia.
official title
Restoration of Central Vision With the PRIMA Products in Patients With Photoreceptor Degeneration