Safety and efficacy of the Alpha AMS subretinal implant
Research type
Research Study
Full title
Safety and efficacy of the Alpha AMS subretinal implant for partial restoration of vision in visually impaired participants with degenerative retinal disease.
IRAS ID
153522
Contact name
Robert MacLaren
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The aim of this single-centre study is to assess the safety and efficacy of the Alpha AMS electronic sub-retinal implant (Retina Implant AG, Reutlingen, Germany) in participants with severe visual impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). The specific research questions are, firstly, can the implant partially restore vision to an eye with no light perception and secondly, what are the safety implications for the ocular and periorbital tissues of the implanted eye? In advanced RP the light detecting photoreceptor cells of the retina degenerate slowly over time, and may eventually lead to blindness. The subretinal implant replaces the degenerate photoreceptor layer and stimulates the residual overlying healthy retinal layers in response to a light stimulus. These signals are then carried on to the brain along the normal visual pathway. We are seeking to recruit six participants who fulfill our eligibility criteria, which include advanced RP with no useful light perception vision in the eye to receive the implant. Participants must be aged between 18 and 70 years old, be highly motivated, and be well enough for a general anaesthetic. The eye must have also had cataract surgery. The project will be conducted at the Oxford Eye Hospital by Chief Investigator Prof Robert MacLaren. Those participants selected to receive the implant will be followed for 12 months from the date of surgery. Between week 1 and month 12 there will be 7 outpatient clinic visits for a range of visual tests and eye assessments including a mobility questionnaire. After 12 months the trial will officially end, however we will continue to review all research participants in clinic as would be standard care for a patient with RP. The implant may be removed at any stage e.g. when it ceases to function or at the participant’s request..
REC name
London - Dulwich Research Ethics Committee
REC reference
15/LO/0445
Date of REC Opinion
7 Apr 2015
REC opinion
Further Information Favourable Opinion