USA (Pittsburgh) feasibility study


Introduction


Title of the study

PRIMA US-Feasibility Study in Atrophic Dry AMD - Age Related Macular Degeneration (PRIMA-FS-US)

Link to ClinicalGov

USA (Pittsburgh) ClinicalTrials.Gov NCT 03392324

Device evaluated

PRIMA, a novel miniature wireless photovoltaic sub-retinal implant

Indication

Dry-age related macular degeneration

Number of patients

 5

STATUS :

RECRUITING

Details

In UPMC Pittsburgh (USA), recruitment is fully active, please check the main inclusion criteria below and contact the
participating center in order to have more information about the study.
PRIMA was implanted in 5 patients in the
feasibility study in Paris: European (France) feasibility study ClinicalTrials.Gov NCT 03333954

Participating center

UPMC : UPMC Eye Center (PA, USA)
Contact : Joseph Martel, MD Pittsburgh, Pennsylvania, United States, 15213
Tel: 412-647-2200

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 complication rates, at 12 months after implantation. Secondary endpoints include visual perception at 3,6,9,18, 24 and 36 months,visual acuity measured by ETDRS, near visual acuity measured by FrACT at 3,6,9,12,18,24 and 36 months, and reading acuity measured at 12, 18, 24 and 36 months 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 logMAR 1.3 (20/400) or worse in both eyes measured by ETDRS;
  • . Has a central scotoma in the study eye with no perception at 0 dB on MP-1 micro-perimetry scale;
  • . Has a refraction of study eye between -3 and + 4 (limits included) for patients with IOL (there is no refraction criteria for phakic patients);

Contact


Contact : Joseph Martel, MD

Pittsburgh, Pennsylvania, United States, 15213

Tel: 412-647-2200