NCT02227498

Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Second Sight Medical Products · Industry
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with severe age-related macular degeneration (AMD). The Argus II System has already been studied in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of the retina are irrevocably damaged and the Argus II System has been found to restore some basic visual function. On these grounds, the device has received authorization for use on the European market (the CE certification) in 2011.

Detailed description

In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with the Argus II System. The study will evaluate the safety of the device and surgery, as well as functioning of the system and the extent of any restored vision. Each subject will be followed for 3 years, with their eye health and visual function tested at multiple time points.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	Effect of Argus II on Functional Vision	To evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD.

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-09-01
• Completion: 2020-03-01
• First posted: 2014-08-28
• Last updated: 2020-03-18

Locations

1 site across 1 country: United Kingdom