Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD

NCT04676854 | Active Not Recruiting DMC

• 1 other identifier: CIP-PV-M
• Study Type: interventional
• Target: 38
• Locations: 6 countries
• Sites: 21

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).

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with meaningful improvement of visual acuity

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

  12 months

• Serious Adverse Events

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

  12 months

Secondary Outcomes (7)

• 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

• Adverse Events

  6, 12, 24, 36 months

Study Arms (1)

PRIMA Bionic Vision System

EXPERIMENTAL

Device: PRIMA Bionic Vision System

Interventions

PRIMA Bionic Vision System DEVICE

Implantation of PRIMA, Vision training, follow up

PRIMA Bionic Vision System

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.) ;
• Has any disease or condition that prevents adequate examination (including 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 epileptic seizures;

Sponsors & Collaborators

• Science Corporation: lead

Study Sites (21)

Hôpital Pellegrin

Bordeaux, 33000, France

Location

Centre hospitalier intercommunal de Créteil - Service Ophtalmologie

Créteil, 94000, France

Location

Hôpital de la Croix-Rousse CHU de LYON

Lyon, 69004, France

Location

Centre Monticelli Paradis

Marseille, 13008, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hopital des Quinze Vingts

Paris, 75012, France

Location

Fondation Ophtalmologique A. De Rothschild

Paris, 75019, France

Location

Universitätsklinikum Aachen, Klinik fuer Augenheilkunde

Aachen, 52074, Germany

Location

Universitäts-Augenklinik Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Hamburg-Eppendorf (UKE), Augenklinik

Hamburg, 20251, Germany

Location

Klinikum Ludwigshafen -Augenklinik

Ludwigshafen am Rhein, 67063, Germany

Location

Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde

Lübeck, 23538, Germany

Location

Augenklinik der Ludwig-Maximilian Universität München

Munich, 80336, Germany

Location

Universitäts-Augenklinik Münster

Münster, 48149, Germany

Location

KNAPPSCHAFTSKLINIKUM SAAR GMBH Augenklinik Sulzbach

Sulzbach, 66280, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, 89075, Germany

Location

Università di Roma Tor Vergata - Policlinico Tor Vergata (PTV), Dipartimento di Medicina Sperimentale - Oftalmologia

Roma, 00133, Italy

Location

Rotterdam Eye Hospital

Rotterdam, Schiedamse Vest 160, 3011 BH, Netherlands

Location

Instituto de Microcirugía Ocular de Barcelona

Barcelona, 08035, Spain

Location

Moorfields Eye Hospital NHS Foundation Trust

London, 0207 566 2117, United Kingdom

Location

Related Publications (2)

• Palanker D, Le Mer Y, Mohand-Said S, Muqit M, Sahel JA. Photovoltaic Restoration of Central Vision in Atrophic Age-Related Macular Degeneration. Ophthalmology. 2020 Aug;127(8):1097-1104. doi: 10.1016/j.ophtha.2020.02.024. Epub 2020 Feb 25.

  PMID: 32249038 BACKGROUND

• Holz FG, Le Mer Y, Muqit MMK, Hattenbach LO, Cusumano A, Grisanti S, Kodjikian L, Pileri MA, Matonti F, Souied E, Stanzel BV, Szurman P, Weber M, Bartz-Schmidt KU, Eter N, Delyfer MN, Girmens JF, van Overdam KA, Wolf A, Hornig R, Corazzol M, Brodie F, Olmos de Koo L, Palanker D, Sahel JA. Subretinal Photovoltaic Implant to Restore Vision in Geographic Atrophy Due to AMD. N Engl J Med. 2026 Jan 15;394(3):232-242. doi: 10.1056/NEJMoa2501396. Epub 2025 Oct 20.

  PMID: 41124203 DERIVED

Related Links

• Pixium Vision

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: November 24, 2020
• Primary Completion: February 1, 2024
• Study Completion (Estimated): February 1, 2028
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); IT (1); FR (7); DE (10); ES (1); NL (1)