Loading clinical trials...

Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration

Restoration of Central Vision With the PRIMA Products in Patients With Photoreceptor Degeneration

NCT07266584•Science Corporation

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 during the PRIMA Stim implantation);
•2. Underwent intraocular lens implantation in the study eye within the last month prior to enrolment (this corresponds to 4 weeks or 28 days) ;
•3. Has an implanted IOL in the study eye and a refraction of the study eye outside of -4D; +4D limit (this criterion is not relevant for phakic eyes)
•4. Has a highly myopic study eye (\>26 mm AP);
•5. Has no light perception in either eye;
•6. Has a history of documented choroidal neovascularization in either eye;
•7. Has any signs of exudative AMD including exudative AMD with detachment of retinal pigment epithelium in the central visual field of the study eye;
•8. Has an implanted telescope in one eye;
•9. Has a black IOL in the study eye;
•10. Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye or the visual system (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, Proliferative Diabetic Retinopathy (PDR), diabetic macular oedema (DME), severe Non-Proliferative Diabetic Retinopathy (NPDR), retinal detachment, infectious or inflammatory retinal disease, severe glaucoma, optic neuropathy, etc.) ;
+25 more criteria

Locations (1)

Sydney Eye Hospital

Sydney, New South Wales, Australia

Key Dates

Start Date

December 1, 2025

Primary Completion Date

January 1, 2029

Completion Date

January 1, 2031

Last Updated

December 5, 2025

Enrollment

ESTIMATED participants

Conditions

Stargardt DiseaseRetinitis Pigmentosa (RP)Inherited Retinal Degeneration

Interventions

PRIMA Products

DEVICE

Contacts

Ralf Hornig, PhD

CONTACT

+33185731835 clinical-trial@science.xyz

A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)

NCT07161544

Stargardt Disease

View study

RECRUITINGPHASE1/PHASE2

Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease

NCT07439887

Stargardt Disease

View study

RECRUITINGNA

Implementation and Evaluation of a Post-Diagnostic Announcement Protocol at the CRMR RefeRet, Quinze-Vingts Hospital

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration

Inclusion Criteria

Exclusion Criteria

A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)

Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease

Implementation and Evaluation of a Post-Diagnostic Announcement Protocol at the CRMR RefeRet, Quinze-Vingts Hospital

A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)

Oral Metformin for Treatment of ABCA4 Retinopathy

A Phase 1/2, First-in-Human Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Subretinal Injection of SB-007 in Subjects With Stargardt Disease (STGD1)