Dry Age-related Macular DegenerationPRIMA-FS-USNCT03392324
PRIMA US-Feasibility Study in Atrophic Dry AMD
A study testing PRIMA in people with Dry Age-related Macular Degeneration, run by Science Corporation at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dry Age-related Macular Degeneration
- What is being tested?
- PRIMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Apr 2018to 20 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 38Show fewer
- 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;
- Has another active implanted device;
- Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis;
- Is an immune-suppressed subject;
- Is 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 present study;
- Has recurrent or chronic inflammations or infections;
- 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;
- Has head dimensions that are incompatible with the Visual Interface;
- Has too high and unrealistic expectation;
- Detailed patient criteria will be verified by the study doctor.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bascom Palmer Eye Institute
Miami, Florida, 33136
Byers Eye Institute-Stanford University
Palo Alto, California, 94303
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Atrophic Dry Age Related Macular Degeneration
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.
Read the detailed description
PRIMA is a new photovoltaic sub-retinal wireless prosthesis for partial restoration of visual perception in patients with vision loss from atrophic dry Age-related Macular Degeneration. The implantable part of the device is placed under the retina. A mini camera mounted on a pair of glasses captures the visual scene in the environment. The visual scene is processed and simplified by the pocket computer connected to the glasses in order to extract useful information from the images. The simplified images are then sent back to the glasses where a miniaturized projector then projects the processed images wirelessly via pulses of near infrared light on the PRIMA implant at the back of the eye under the retina. The photovoltaic cells convert this optical information into electrical stimulation to excite the nerve cells of the retina and induce visual perception. In this early feasibility study five human subjects suffering from atrophic dry age related macular degeneration will receive the implant. The performance and the safety of the device will be monitored for up to 36 months.
- Conditions
- Dry Age-related Macular Degeneration
- Being tested
- PRIMA
- Keywords
- atrophic macular degeneration, geographic atrophy, retina implant, retinal prosthesis, visual prosthesis, macular degeneration, dry macular degeneration, AMD
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIMADevice
Implantation of PRIMA device
| Study group | Role | What they receive |
|---|---|---|
| PRIMA | Experimental | Implantation of PRIMA device Receives: Device: PRIMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Visual Acuity
Near Visual acuity measured by FrACT
Measured: 12 months after implantation
Secondary outcomes (4)
Near Visual Acuity
Near Visual acuity measured by FrACT
Measured: 3, 6, 9, 18, 24, and 36 months after implantation
Visual Acuity
Visual acuity measured by ETDRS
Measured: 3, 6, 9, 12, 18, 24 and 36 months after implantation
Reading Acuity Test
Reading acuity measured by Radner Charts
Measured: 6, 12, 24, 36 months after implantation
Quality of Life Questionnaire
The change in quality of life is measure by the Impact of Vision Impairment (IVI) Questionnaire
Measured: 12, 24, and 36 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start26 Apr 2018
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age-related Macular DegenerationStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Martel, MD, Principal investigator, UPMC Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392324
- Sponsor's protocol ID
- CIP-PRIMA-FS-US
- Acronym
- PRIMA-FS-US
- Status last verified
- Mar 2026
- First submitted
- 29 Dec 2017
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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
- Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Atrophic Dry Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03392324
- Acronym / sponsor ID
- PRIMA-FS-US / CIP-PRIMA-FS-US
- Conditions
- Dry Age-related Macular Degeneration
- Keywords
- atrophic macular degeneration, geographic atrophy, retina implant, retinal prosthesis, visual prosthesis, macular degeneration, dry macular degeneration, AMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Science CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 5 Jan 2018 (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.
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.
Detailed description
PRIMA is a new photovoltaic sub-retinal wireless prosthesis for partial restoration of visual perception in patients with vision loss from atrophic dry Age-related Macular Degeneration. The implantable part of the device is placed under the retina. A mini camera mounted on a pair of glasses captures the visual scene in the environment. The visual scene is processed and simplified by the pocket computer connected to the glasses in order to extract useful information from the images. The simplified images are then sent back to the glasses where a miniaturized projector then projects the processed images wirelessly via pulses of near infrared light on the PRIMA implant at the back of the eye under the retina. The photovoltaic cells convert this optical information into electrical stimulation to excite the nerve cells of the retina and induce visual perception. In this early feasibility study five human subjects suffering from atrophic dry age related macular degeneration will receive the implant. The performance and the safety of the device will be monitored for up to 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRIMA | Experimental | Device: PRIMAImplantation of PRIMA device |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- 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:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PRIMAImplantation of PRIMA device | Device | PRIMA |
Primary outcome
Near Visual Acuity
Time frame: 12 months after implantation
Near Visual acuity measured by FrACT
4 secondary outcomes
Near Visual Acuity
Time frame: 3, 6, 9, 18, 24, and 36 months after implantation
Visual Acuity
Time frame: 3, 6, 9, 12, 18, 24 and 36 months after implantation
Reading Acuity Test
Time frame: 6, 12, 24, 36 months after implantation
Quality of Life Questionnaire
Time frame: 12, 24, and 36 months after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Science corporationLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Joseph Martel, MD principal investigator
UPMC Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIMA in people with Dry Age-related Macular Degeneration, run by Science Corporation at 3 sites in United States.
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 38 inclusion and 0 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: finished, 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 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near Visual Acuity (time frame: 12 months after implantation). 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.