Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorScience Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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);
Trial design
Design model
Single group
Treatments tested in this trial
PRIMA Products
DeviceImplantation of PRIMA, Vision training, follow up
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: PRIMA ProductsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with an improvement of visual acuity
Proportion of participants with an improvement of visual acuity of logMAR 0.2 or more
Time frame
12 months2
Number and severity of device and procedure related serious adverse events
Number and severity of device and procedure related serious adverse events
Time frame
12 monthsSecondary outcomes
1
Proportion of participants with an improvement of visual acuity
Proportion of participants with an improvement of visual acuity of logMAR 0.2 or more
Time frame
6, 24 and 36 months2
Mean improvement in visual acuity
Mean improvement in visual acuity measured by ETDRS (extended by the Berkeley Rudimentary Vision Test)
Time frame
6, 12, 24 and 36 months3
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.
Time frame
12, 24 and 36 months4
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
Time frame
up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov