Argus II Retinal Prosthesis System - Better Vision RP Study

NCT03418116 | Withdrawn DMC FDA Device

• 1 other identifier: CP-08-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

The study is conducted to evaluate the safety and benefit of the Argus II System in a selected patient population with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius.

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (2)

• Adverse events

  The nature and number of adverse events in implanted subjects.

  2 Years

• Visual field

  The effect of the Argus II System on visual field size, as measured by Goldmann perimetry

  2 Years

Secondary Outcomes (3)

• Visual function

  2 Years

• Quality of Life

  2 Years

• Functional vision and quality of life

  2 Years

Study Arms (1)

Argus II

EXPERIMENTAL

Implantation of the Argus II Retinal Prosthesis in patients with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius. The array will be placed parafoveally, adjacent to the preserved central visual field (i.e., "tunnel vision") in these subjects.

Device: Argus II Retinal Prosthesis

Interventions

Argus II Retinal Prosthesis DEVICE

The Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light.

Argus II

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, age 25 years or older;
• Diagnosed with advanced Retinitis Pigmentosa (including syndromic RP), Choroideremia, Leber's Congenital Amaurosis, or Rod-Cone disease;
• A measurable central residual visual field of 5° radius or smaller in both eyes, as determined by Goldmann perimetry;
• Visual acuity of 0.1 (1.0 logMAR) or worse in the eye to be implanted, as measured by ETDRS chart;
• Previous history of useful form vision;
• Provided written, informed consent to participate in the study.

You may not qualify if:

• Ocular diseases or conditions that could prevent the Argus II implant from working (e.g., optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, etc.);
• Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length \<20.5 mm or \> 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.);
• Pre-disposition to eye rubbing;
• Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
• cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,
• psychiatric disease including diagnosed forms of depression;
• does not speak a principal language associated with the region, and
• deafness or selective frequency hearing loss that prevents hearing device alarms and alerts;
• Pregnant or wish to become pregnant during the course of the study;
• Participating in another investigational drug or device study that may conflict with the objectives, follow-up, or testing of this study;
• Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery;

Sponsors & Collaborators

• Second Sight Medical Products: lead

Study Sites (3)

Augenklinik Städtisches Klinikum Karlsruhe

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

University Medical Center Schleswig-Holstein, Department of Ophthalmology

Lübeck, Schleswig-Holstein, 23538, Germany

Location

RWTH University Eye Clinic

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Peter Walter, Prof Dr med

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 1, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

DE (3)