RP Cure Tracker

Trials / NCT03629899

RETINA IMPLANT Alpha AMS in Blind Patients With Retinitis Pigmentosa

Withdrawn N/A Gene therapy, Retinal implant

Why it stopped: unavailability of the investigational device

Sponsor
Wills Eye
Treatment
RETINA IMPLANT Alpha AMS
Gene
Not stated
Conditions
Retinitis Pigmentosa
Ages
50 Years to no upper limit
Enrollment
Not stated participants
Started
2019-03
Main results expected
2025-07
Results posted
Not yet
Record last updated
2019-05-10

What the study is testing

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.

Where it runs

United States (1)

Open on ClinicalTrials.gov for contacts and eligibility