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Withdrawn N/A Gene therapy, Retinal implant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)
- Wills Eye Hospital, Philadelphia, Pennsylvania