Restoration of Central Vision With the PRIMA Products in Patients With Photoreceptor Degeneration
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Science Corporation
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Proportion of participants with an improvement of visual acuity
Overview
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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •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.) ;
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- Change of natural visual acuity(up to 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)