Restoration of Central Vision With the PRIMA System in Patients With Atrophic Age-Related Macular Degeneration

Science Corporation21 sites in 6 countries38 target enrollmentNovember 24, 2020

ConditionsGeographic Atrophy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Geographic Atrophy
Sponsor: Science Corporation
Enrollment: 38
Locations: 21
Primary Endpoint: Proportion of subjects with meaningful improvement of visual acuity
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials Related News

Overview

Brief Summary

The objective of this study is to evaluate the efficacy and safety of the PRIMA System in patients with atrophic AMD. Eligible subjects will be implanted with the PRIMA Implant. The subjects will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA System (Implant and Visual Processor).

Registry

clinicaltrials.gov

Start Date

November 24, 2020

End Date

February 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Science Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is 60 years or older at the date of inclusion;
•Has a confirmed diagnosis of geographic atrophy due to AMD 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;
•Patient signed informed consent

Exclusion Criteria

•Has cataract in the study eye (with LOCS III scale NO, NC, C or P\>1); (these patients will be asked to have cataract surgery performed prior to enrollment; all other patients will get IOL replacement during the PRIMA implantation);
•Underwent intra ocular lens implantation in the study eye within the last month ;
•Has a highly myopic study eye (\>26 mm AP);
•Has a highly hyperopic study eye (\<20 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 edema (DME), severe Non-Proliferative Diabetic Retinopathy (NPDR), retinal detachment, infectious or inflammatory retinal disease, severe glaucoma, optic neuropathy, etc.) ;

Outcomes

Primary Outcomes

Proportion of subjects with meaningful improvement of visual acuity

Time Frame: 12 months

Proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline to 12 months

Serious Adverse Events

Time Frame: 12 months

Number and severity of device and procedure related serious adverse events at 12 months follow-up

Secondary Outcomes

Adverse Events(6, 12, 24, 36 months)
Proportion of subjects with meaningful improvement of visual acuity(6, 24, 36 months)
Improvement of visual acuity(6, 12, 24, 36 months)
Quality of life measured by IVI(6, 12, 24, 36 months)
Central visual perception(12 months)
Change of natural visual acuity(6, 12, 24, 36 months)
Proportion of compliant implantations(4 weeks after implantation)