Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration

NCT07266584 | Recruiting

• 1 other identifier: CIP-PRIMA-AUS
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Stargardt Disease; Retinitis Pigmentosa (RP); Inherited Retinal Degeneration

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with an improvement of visual acuity

  Proportion of participants with an improvement of visual acuity of logMAR 0.2 or more

  12 months

• Number and severity of device and procedure related serious adverse events

  Number and severity of device and procedure related serious adverse events

  12 months

Secondary Outcomes (5)

• Proportion of participants with an improvement of visual acuity

  6, 24 and 36 months

• Mean improvement in visual acuity

  6, 12, 24 and 36 months

• Mean improvement in the reading test

  12, 24 and 36 months

• Number and severity of procedure and device related adverse events throughout the study

  up to 36 months

• Change of natural visual acuity

  up to 36 months

Study Arms (1)

PRIMA Products

EXPERIMENTAL

Device: PRIMA Products

Interventions

PRIMA Products DEVICE

Implantation of PRIMA, Vision training, follow up

PRIMA Products

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a confirmed diagnosis of inherited retinal degeneration with the macula affected in both eyes;
• The study eye has best corrected visual acuity of logMAR 1.2 (20/320) or worse as measured by ETDRS test;
• 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);
• Understands the constraints of the study and accepts to present for all scheduled follow-up visits;
• Signed the informed consent.

You may not qualify if:

• \. 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);
• Underwent intraocular lens implantation in the study eye within the last month prior to enrolment (this corresponds to 4 weeks or 28 days) ;
• 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)
• Has a highly myopic study eye (\>26 mm AP);
• Has no light perception in either eye;
• Has a history of documented choroidal neovascularization in either eye;
• Has any signs of exudative AMD including exudative AMD with detachment of retinal pigment epithelium in the central visual field of the study eye;
• Has an implanted telescope in one eye;
• Has a black IOL in the study eye;
• 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.) ;
• Has any disease or condition that prevents adequate examination (including Optical Coherence Tomography (OCT)) of the study eye including but not limited to media opacities that cannot be resolved prior to implantation. Note, that this criterion is also important for the function of the implant;
• 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 (e.g., deafness, severe multiple sclerosis, amyotrophic lateral sclerosis, severe neuritis, etc.);
• Has uncontrolled epileptic seizures;

Sponsors & Collaborators

• Science Corporation: lead

Study Sites (1)

Sydney Eye Hospital

Sydney, New South Wales, 2006, Australia

RECRUITING

Related Links

• Science Corporation

MeSH Terms

Conditions

Stargardt Disease; Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinal Dystrophies

Central Study Contacts

Ralf Hornig, PhD

CONTACT

+33185731835; clinical-trial@science.xyz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 5, 2025
• Study Start: March 12, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)