Pixium Augmentation

Overview


PRIMA sub-retinal wireless photovoltaic bionic vision system clinical studies in Europe and USA for atrophic dry-AMD



PRIMA was designed for vision loss from retinal dystrophies, initially atrophic Dry AMD, (Age Related Macular Degeneration) and subsequently retinitis pigmentosa. The first in human feasibility studies are being conducted in parallel in Europe (France) and US (Pittsburgh).

  • · Title of the study: Feasibility Study of Compensation for Blindness with the PRIMA System in Patients with Dry Age Related Macular Degeneration (PRIMA FS and PRIMA-FS-US)
  • · Reference NCT03333954 for the European study and NCT03392324 for the USA study

The objective of both studies is to assess elicitation of visual perception by electrical stimulation of the PRIMA implant, including safety assessment and complication rates. 
In the USA visual acuity and reading capability will be measured in addition. Currently the benefit for the patient is not yet known. The study is an open-label, non-randomized, clinical trial.

Reference of the study

European study

FS PRIMA

American study

PRIMA-FS-US

Estimated Enrollment:

Up to 5 implanted subjects

Up to 5 implanted subjects

Study Start Date:

November 2017

April 2018

Primary endpoints

Elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment after implantation

Elicitation of visual perception by electrical stimulation of the PRIMA implant and complication rates, at 12 months after implantation

Secondary end points


Assessments at 1 day, 1 week, 6 weeks, 3, 6, 9 , 12, 18, 24 and up to 36 months

IRIS®II Epi-retinal bionic vision system study



IRIS II was designed for retinal dystrophies such as retinitis pigmentosa. Enrollment of this clinical trial has been closed. The study is ongoing but not recruiting patients. The IRIS® II clinical trial, started in January 2016, is a multi-centric, open label, non-randomized prospective European study to assess effectiveness of the IRIS® II Bionic Vision System as treatment intended to compensate for blindness.



Link to the clinical.gov study

Reference NCT02670980

IRIS®II

Patients Enrollment:

10 patients, completed

Study Start Date:

January, 2016

Estimated study Completion Date:

January, 2020