Stargardt DiseasePRIMAliaNCT07266584
Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration
A study testing PRIMA Products in people with Stargardt Disease and Retinitis Pigmentosa (RP), run by Science Corporation at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stargardt Disease, Retinitis Pigmentosa (RP), Inherited Retinal Degeneration
- What is being tested?
- PRIMA Products
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Apr 2026to 1 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
- 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;
Show all 35Show fewer
- 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;
- Has a known sensitivity to the contact materials of the implant (iridium oxide, silicon-carbide and titanium);
- Has a known allergy to anaesthetic drugs;
- Presents with hypotonia in the study eye (<8 mmHg);
- Presents with hypertonia in the study eye (>23 mmHg with treatment);
- Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis;
- Is an immune-suppressed participant (e.g., due to HIV positive diagnosis, etc.);
- Is a known carrier of multi-resistant microorganisms;
- Is receiving anticoagulation therapy that cannot be adapted to allow eye surgery;
- Is participating in another investigational drug or device study that may interfere with the PRIMAlia study;
- Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study;
- Has significant recurrent or chronic inflammations or infections. Specifically, patients with the following disorders are excluded:
- Severe chronic and consuming diseases that frequently associated with infection (e.g. Crohn disease, Whipple's disease);
- Active inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, hordeolum, chalazion);
- Has a severe psychological disorder;
- Does not have the mental capacity to legally sign the informed consent;
- Has severe renal, cardiac, hepatic, etc. organ diseases (ASA IV or worse);
- Has head dimensions that are incompatible with the PRIMA Companion glasses;
- Has too high and/or unrealistic expectations (e.g., believes that a benefit is guaranteed or expects normal vision after surgery).
- Physical constraints making use of PRIMA or rehabilitation impossible
- Participant who, in the opinion of the investigator, is not suitable for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Sydney Eye Hospital
Sydney, New South Wales, 2006
Matthew Simunovic, Prof., +61 2 9382 7111, catherine.le@sydney.edu.au
About this study
Official title: Restoration of Central Vision With the PRIMA Products 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 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.
Read the 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.
- Being tested
- PRIMA Products
- Medical subject headings
- Stargardt Disease, Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIMA ProductsDevice
Implantation of PRIMA, Vision training, follow up
| Study group | Role | What they receive |
|---|---|---|
| PRIMA Products | Experimental | Not described Receives: Device: PRIMA Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with an improvement of visual acuity
Proportion of participants with an improvement of visual acuity of logMAR 0.2 or more
Measured: 12 months
Number and severity of device and procedure related serious adverse events
Number and severity of device and procedure related serious adverse events
Measured: 12 months
Secondary outcomes (5)
Proportion of participants with an improvement of visual acuity
Proportion of participants with an improvement of visual acuity of logMAR 0.2 or more
Measured: 6, 24 and 36 months
Mean improvement in visual acuity
Mean improvement in visual acuity measured by ETDRS (extended by the Berkeley Rudimentary Vision Test)
Measured: 6, 12, 24 and 36 months
Mean improvement in the reading test
Mean improvement in reading acuity, measured using the Radner Reading Charts and reported on the logRAD (Reading Acuity Determination) scale. The logRAD scale ranges from 1.2 logRAD (worst reading acuity) to -0.2 logRAD (best reading acuity) at 40 cm. Lower logRAD values indicate better reading acuity.
Measured: 12, 24 and 36 months
Number and severity of procedure and device related adverse events throughout the study
Number and severity of procedure and device related adverse events throughout the study
Measured: up to 36 months
Change of natural visual acuity
Change of natural visual acuity from baseline without the PRIMA Companion glasses measured by ETDRS (extended by the Berkeley Rudimentary Vision Test)
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start22 Apr 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stargardt DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266584
- Sponsor's protocol ID
- CIP-PRIMA-AUS
- Acronym
- PRIMAlia
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Central Vision With the PRIMA Products in Patients With Photoreceptor Degeneration
- ClinicalTrials.gov ID
- NCT07266584
- Acronym / sponsor ID
- PRIMAlia / CIP-PRIMA-AUS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Science CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRIMA Products | Experimental | Device: PRIMA Products |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (35 listed)
- 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);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIMA ProductsImplantation of PRIMA, Vision training, follow up | Device | PRIMA Products |
Primary outcome
Proportion of participants with an improvement of visual acuity
Time frame: 12 months
Proportion of participants with an improvement of visual acuity of logMAR 0.2 or more
Number and severity of device and procedure related serious adverse events
Time frame: 12 months
Number and severity of device and procedure related serious adverse events
5 secondary outcomes
Proportion of participants with an improvement of visual acuity
Time frame: 6, 24 and 36 months
Mean improvement in visual acuity
Time frame: 6, 12, 24 and 36 months
Mean improvement in the reading test
Time frame: 12, 24 and 36 months
Number and severity of procedure and device related adverse events throughout the study
Time frame: up to 36 months
Change of natural visual acuity
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Science CorporationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIMA Products in people with Stargardt Disease and Retinitis Pigmentosa (RP), run by Science Corporation at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ralf Hornig, PhD (+33185731835, clinical-trial@science.xyz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with an improvement of visual acuity (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.