Safety and Efficacy of the Alpha AMS Subretinal Implant
NCT02720640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2017-11-17
Summary
The aim of this single-centre study is to assess the safety and efficacy of the Retina Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe visual impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). The study is sponsored by the University of Oxford and funded by the National Institute for Health Research (UK).
Conditions
Interventions
- DEVICE
-
Implant 'on' vs implant 'off'
Single group assignment
Sponsors & Collaborators
-
University of Oxford
lead OTHER
Principal Investigators
-
Robert E MacLaren, DPhil FRCS · 1. Nuffield Laboratory of Ophthalmology, Department of Clinical Neurosciences, University of Oxford; 2. Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust; 3. Moorfields Eye Hospital NHS Foundation Trust, London
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2017-10-31
- Completion
- 2017-10-31
Countries
- United Kingdom
Study Locations
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