Status:
WITHDRAWN
Argus II Retinal Prosthesis System - Better Vision RP Study
Lead Sponsor:
Second Sight Medical Products
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
25+ years
Phase:
NA
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...
Detailed Description
The Argus II System is intended for use in blind patients with severe to profound retinitis pigmentosa with at least some light perception in the eye to be implanted. The majority of RP patients stil...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Conditions likely to limit life to less than 1 year from the time of inclusion.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03418116
Start Date
November 1 2018
End Date
November 1 2021
Last Update
June 25 2019
Active Locations (3)
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1
Augenklinik Städtisches Klinikum Karlsruhe
Karlsruhe, Baden-Wurttemberg, Germany, 76133
2
University Medical Center Schleswig-Holstein, Department of Ophthalmology
Lübeck, Schleswig-Holstein, Germany, 23538
3
RWTH University Eye Clinic
Aachen, Germany, 52074