MedTrace Logo

RETINA IMPLANT Alpha AMS in Blind Patients With Retinitis Pigmentosa

NCT03629899 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-05-10

No results posted yet for this study

Summary

The goal of this study is to transfer the surgical implantation technique and evaluate the safety and effectiveness of the RETINA IMPLANT Alpha AMS to restore limited visual function and functional vision in blind Retinitis Pigmentosa (RP) patients who are at the Light Perception (LP) or No Light Perception vision level (NLP). The safety of the implantation procedure and the long-term presence of the RETINA IMPLANT Alpha AMS will be assessed with clinical exams and objective clinical tests for the absence of any new permanent damage to the structure and function of the implanted eye with no permanent injury to the health and/or well being of the implanted patient as a result of the surgical procedure or presence of the implant. The effectiveness of the RETINA IMPLANT Alpha AMS will be evaluated by measuring limited visual function and functional vision in implanted subjects with the device "ON" and "OFF" in a randomized order. The ability to restore limited vision in blind RP patients with LP vision or NLP will reduce their disability and morbidity and provide a viable option to combat their disease and improve their lives.

Conditions

Interventions

DEVICE

RETINA IMPLANT Alpha AMS

Implantation of the subretinal RETINA IMPLANT Alpha AMS

Sponsors & Collaborators

  • Retina Implant AG

    collaborator INDUSTRY

  • Wills Eye

    lead OTHER

Principal Investigators

  • Jay Federman, MD · Wills Eye Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03629899 on ClinicalTrials.gov