European (Paris, France) feasibility study


Introduction


Title of the study

Feasibility Study of Compensation for Blindness with the PRIMA System in Patients with Dry AMD-Age Related Macular Degeneration (PRIMA FS)

Link to ClinicalGov

Europe (Paris, France) ClinicalTrials.Gov NCT 03333954

Device evaluated

PRIMA, a novel miniature wireless photovoltaic sub-retinal implant

Indication

Dry- age related macular degeneration (dry AMD)

Number of patients

5

STATUS

RECRUITMENT COMPLETED, study ongoing

Details

PRIMA was successfully implanted in 5 patients in the French feasibility study.

The patients, up to now 4 out of 5, had all visual perceptions by electrical stimulation of PRIMA and they are now pursuing their reeducation phase as per protocol.

Interim results are expected by the end of the year 2018.

Participating centers

Fondation Ophtalmologique de Rothschild, Paris (France)

Contact: Dr. Yannick Le Mer
29, Rue Manin, 75019 Paris, France
Tel: +33 1 48 03 65 65

Hôpital des Quinze-Vingts, Paris (France)

Contact : Dr. Saddek Mohand-Said
28, Rue de Charenton, 75012 Paris, France
Tel: +33 1 40 02 14 04

Evaluation Criteria


The principal evaluation criterion of the trial is safety and performance evaluation : , elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates after implantation.

Main Inclusion Criteria

  • · Is 60 years or older at the date of enrollment;
  • · Has a confirmed diagnosis of advanced dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters;
  • · Has best corrected visual acuity of the study eye of 20/400 (logMAR 1.3) or worse measured by ETDRS; (beyond legal blindness)

· Has no foveal perception measured by micro-perimetry in the study eye (≤ 4 dB on Opko scale or equivalent);