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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Implantation of PRIMA, Vision training, follow up
Sydney Eye Hospital
Sydney, New South Wales, Australia
Proportion of participants with an improvement of visual acuity
Proportion of participants with an improvement of visual acuity of logMAR 0.2 or more
Time frame: 12 months
Number and severity of device and procedure related serious adverse events
Number and severity of device and procedure related serious adverse events
Time frame: 12 months
Proportion of participants with an improvement of visual acuity
Proportion of participants with an improvement of visual acuity of logMAR 0.2 or more
Time frame: 6, 24 and 36 months
Mean improvement in visual acuity
Mean improvement in visual acuity measured by ETDRS (extended by the Berkeley Rudimentary Vision Test)
Time frame: 6, 12, 24 and 36 months
Mean improvement in the reading test
Mean improvement in the reading test
Time frame: 12, 24 and 36 months
Number and severity of procedure and device related adverse events throughout the study
Number and severity of procedure and device related adverse events throughout the study
Time frame: up to 36 months
Change of natural visual acuity
Change of natural visual acuity from baseline without the PRIMA Companion glasses measured by ETDRS (extended by the Berkeley Rudimentary Vision Test)
Time frame: up to 36 months
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