Actively Recruiting
Restoration of Central Vision With the PRIMA Products in Patients With Photoreceptor Degeneration
Led by Science Corporation · Updated on 2026-04-02
5
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the PRIMA Products to restore limited central vision in people with inherited retinal degeneration affecting the macula, such as Stargardt disease and Retinitis Pigmentosa. This study aims to assess the safety and effectiveness of the PRIMA implant in improving visual function for those who have lost central vision due to photoreceptor cell degeneration. The study is sponsored by Science Corporation Australia and builds on prior successful testing in patients with geographic atrophy. Participants will receive the PRIMA Stim implant designed to stimulate the retina where photoreceptors have degenerated. After implantation, participants will undergo vision training and regular follow-up visits to monitor progress. The study includes assessments at multiple time points over up to 36 months to track changes in visual acuity, reading ability, and any procedure- or device-related adverse events. During the study, participants will complete various visual function tests and functional vision evaluations at scheduled intervals. Researchers will measure the proportion of participants showing improvement in visual acuity at 6, 12, 24, and 36 months, as well as track the severity of any side effects. Participants must commit to attending all follow-up visits and will be monitored closely to collect data supporting continued development and evaluation of the PRIMA Products.
CONDITIONS
Brief Title
Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Is 18 years or older at the date of inclusion
- 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 will not qualify if you...
- Has cataract in the study eye (with LOCS III scale NO, NC, C or P >1) unless cataract surgery is performed before baseline testing
- Underwent intraocular lens implantation in the study eye within the last month prior to enrolment
- Has an implanted intraocular lens in the study eye and refraction outside of -4D to +4D limit (not relevant for phakic eyes)
- Has a highly myopic study eye (>26 mm axial length)
- Has no light perception in either eye
- History of choroidal neovascularization in either eye
- Signs of exudative age-related macular degeneration including detachment of retinal pigment epithelium in the central visual field
- Has an implanted telescope or black intraocular lens in the study eye
- Has other diseases affecting retinal function or visual system (e.g., retinal artery/vein occlusion, end-stage diabetic retinopathy, proliferative diabetic retinopathy, diabetic macular oedema, severe glaucoma, optic neuropathy)
- Has conditions that prevent adequate eye examination including optical coherence tomography
- Corneal endothelial cell count less than 1000 cells/mm² in the study eye
- Suffers from nystagmus or ocular motility disorders
- Has conditions preventing understanding or communication of informed consent or test protocols
- Has uncontrolled epileptic seizures
- Known sensitivity to implant materials (iridium oxide, silicon-carbide, titanium)
- Known allergy to anaesthetic drugs
- Presents hypotonia (<8 mmHg) or hypertonia (>23 mmHg with treatment) in the study eye
- Active cancer or history of intraocular, optic nerve, brain cancer and metastasis
- Immune-suppressed participant (e.g., HIV positive)
- Carrier of multi-resistant microorganisms
- Receiving anticoagulation therapy that cannot be adapted for eye surgery
- Participating in another investigational drug or device study that may interfere
- History of chronic or recurrent infection or inflammation preventing study participation
- Severe chronic diseases associated with infection or active ocular inflammation
- Severe psychological disorder
- Lacks mental capacity to legally sign informed consent
- Severe organ diseases (ASA IV or worse)
- Head dimensions incompatible with PRIMA Companion glasses
- Has unrealistic expectations about study outcomes
- Physical constraints making use of PRIMA or rehabilitation impossible
- Investigator considers participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial procedure and rehabilitation period lasting several weeks
Participants receive implantation of the PRIMA device followed by vision training.
1 implantation visit and multiple training visits
Duration - Up to 36 months
Participants are monitored for safety and efficacy outcomes following implantation and training.
Regular visits for follow-up assessments over 3 years
Trial Site Locations
Total: 1 location
1
Sydney Eye Hospital
Sydney, New South Wales, Australia, 2006
Actively Recruiting
Research Team
R
Ralf Hornig, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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