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

NCT04676854 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-11-29

No results posted yet for this study

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

Interventions

DEVICE

PRIMA Bionic Vision System

Implantation of PRIMA, Vision training, follow up

Sponsors & Collaborators

  • Science Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2024-02-01
Completion
2028-02-29

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676854 on ClinicalTrials.gov