PRIMA US-Feasibility Study in Atrophic Dry AMD
Running, not enrolling · Not applicable
Conditions studied: Dry Age-related Macular Degeneration
In brief
In this early feasibility trial the safety and performance of the new retinal prothesis PRIMA is tested in five subjects suffering from atrophic dry age related macular degeneration.
Key facts
- Study ID
- NCT03392324
- Run by
- Science Corporation
- People needed
- 5
- Starts
- 2018-04-26
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-04-02
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is 60 years or older at the date of inclusion;
- Has a confirmed diagnosis of atrophic dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters in the study eye;
- Has best corrected visual acuity of logMAR 1.3 (20/400) or worse in the study eye measured by ETDRS;
- Has a central scotoma in the study eye with no perception at 0 dB on MP-1 micro-perimetry scale in the visual field covering the central 7 degrees (+/-3.5 degrees) and maximum 20% perception in the remaining visual field covering the central 12 degrees (+/- 6 degrees);
- Meets one of the following criteria in the non-study eye:
- Visual acuity of 20/200 (logMAR 1.0) or worse and an atrophy size <8mm2
- Visual acuity of 20/160 (logMAR 0.9) or worse and an atrophy size ≥8mm2 and ≤12.5 mm2
- Visual acuity of 20/100 (logMAR 0.7) or worse and an atrophy size >12.5 mm2
- Has a refraction of study eye between -3 and + 4 (limits included) for patients with IOL (there is no refraction criteria for phakic patients);
- Understands and accepts the obligation to present for all schedule follow-up visits;
- Patient signed informed consent.
- Main Exclusion Criteria:
- Has cataract in the study ;
- Has an aphakic study eye;
- Has no light perception in the study eye;
- Has a history of choroidal neovascularization in either eye;
- Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye
- Has an implanted telescope in one eye;
- Has any disease or condition that prevents adequate examination of the study
- Has a corneal endothelial cell count of less than 1000 cells/mm² in the study eye
- Suffers from nystagmus or other ocular motility disorders;
- Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols
- Has a history of epileptic seizure;
- Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study;
- Presents with hypotony or hypertony in the study eye;
Where it is running
- Byers Eye Institute-Stanford University — Palo Alto, California, United States
- Bascom Palmer Eye Institute — Miami, Florida, United States
- UPMC Eye Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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