Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration
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 participa
| Condition(s) | Stargardt Disease, Retinitis Pigmentosa (RP), Inherited Retinal Degeneration |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Is 18 years or older at the date of inclusion; 2. Has a confirmed diagnosis of inherited retinal degeneration with the macula affected in both eyes; 3. The study eye has best corrected visual acuity of logMAR 1.2 (20/320) or worse as measured by ETDRS test; 4. Has an atrophic patch in the study eye including the fovea of at least the implant size (\>4.5 mm2 and \>2.4 mm in minimum diameter); 5. Understands the constraints of the study and accepts to present for all scheduled follow-up visits; 6. Signed the informed consent. Exclusion Criteria: 1. 1\. Has cataract in the study eye (with LOCS III scale NO, NC, C or P\>1); (these patients will need to have cataract surgery performed prior to completion of baseline testing; all other patients will get IOL replacement dur |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Science Corporation |
| Locations | Sydney, New South Wales, Australia |
| Start date | 2026-03-12 |
| NCT ID | NCT07266584 |
| Official listing | https://clinicaltrials.gov/study/NCT07266584 |