PRIMAvera
Research type
Research Study
Full title
Restoration of central vision with the PRIMA System in Patients with Atrophic Age-Related Macular Degeneration
IRAS ID
293911
Contact name
Mahi Muqit
Contact email
Sponsor organisation
Pixium Vision SA
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-FR-20-11-035126, Eudamed Number
Duration of Study in the UK
6 years, 1 months, 30 days
Research summary
The purpose of this study is to evaluate the safety and effectiveness of the PRIMA bionic system (PRIMA system). The PRIMA system is a medical device being developed for people with retinal degenerative conditions such as atrophic age-related macular degeneration (or geographic atrophy). In this disease the light sensitive cells in the middle area of the back of the eye are degenerated, which leads to a loss of the central vision.
As of today, this disease represents an unmet medical need.
The PRIMA system aims to partially restore visual function by electrical stimulation of the retina using stimulator surgically implanted under the retina (subretinal). The subretinal implant attempts to partly replace the degenerated photoreceptors associated with atrophic AMD.
Smaller studies have shown the initial safety of the device. However, this study will be the first study to analyse the improvement in visual function with the current version of the device in humans with a larger number of study participants.Patients will be implanted with the PRIMA system,then followed up for 3 years with assessments being carried out at 1 day, 1 week, 1, 3,6,9,12,18,24,30 and 36 months time points. The total study duration is expected to be up to 74 months.
The total subject study duration is expected to be a minimum of 36 months. Including the baseline assessment, this results in a total expected duration of approximately 38 months.REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0202
Date of REC Opinion
11 May 2021
REC opinion
Further Information Favourable Opinion