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Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

This study is currently recruiting participants.
Verified December 2011 by Retina Implant AG
Sponsor:
Information provided by (Responsible Party):
Retina Implant AG
ClinicalTrials.gov Identifier:
NCT01024803
First received: November 26, 2009
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  Purpose

Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight.

Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition.


Condition Intervention
Retinitis Pigmentosa
Retinal Degeneration
 Device: Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Patients With Degenerative Retinal Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Retina Implant AG:

Primary Outcome Measures:
  • Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof. [ Time Frame: every 3 months for a period of one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual acuity/light-perception and/or object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT/BaLM/BaGA/VFQ-25 or a combination thereof. [ Time Frame: every 3 months for a period of one year ] [ Designated as safety issue: Yes ]
  • Patient long term safety and stability of implant function [ Time Frame: every 3 months for a period of one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye

    Surgical implantation of medical device named "Retina Implant" into eye to restore vision partially.

    Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL.

    Other Names:
    • retinal implant
    • bionic eye
    • artificial vision
    • artificial eye
    • restoration of vision
    • eye chip
    • vision prosthesis
    • eye implant
    • retinal prosthesis
  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods & cones.
  • Pseudophakia
  • Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
  • Age between 18 and 78 years.
  • Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation.
  • Ability to read normal print in earlier life, optically corrected without magnifying glass.
  • Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year for Module-2.

Exclusion Criteria:

  • Period of appropriate visual functions approx. 12 years / lifetime.
  • Optical Coherence Tomography (OCT) shows significant retina edema &/or scar tissue within target region for implant.
  • Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT).
  • Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP).
  • Heavy clumped pigmentation at posterior pole
  • Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment).
  • Amblyopia reported earlier in life on eye to be implanted
  • Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases).
  • Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression).
  • Hyperthyroidism or hypersensitivity to iodine
  • Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study.
  • Participation in another interventional clinical trial within the past 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024803

Contacts
Contact: Anuschirawan HEKMAT, Ph.D. +49 7121 36403 ext 251 hekmat@retina-implant.de
Contact: Eberhart Zrenner, MD. Prof. +49 7071 298 ext 4786 ezrenner@uni-tuebingen.de

Locations
Germany
Helmut Sachs, MD, PD Recruiting
Dresden, Germany, 01067
Contact: Ursula Brunner     +49 351 480 1830     brunner@eye-regensburg.de    
Claus Eckardt, MD, Prof. Recruiting
Frankfurt-Hoechst, Germany, 65929
Contact: Ute Reissig, MD     +49 69 3106 2972     C.Eckardt@em.uni-frankfurt.de    
Johann Roider, MD, Prof. Recruiting
Kiel, Germany, 24105
Contact: Jost Hillenkamp, MD, PD     +49 431 597-2402     jhillenkamp@ophthalmol.uni-kiel.de    
Karl-Ulrich Bartz-Schmidt, MD, Prof. Recruiting
Tuebingen, Germany, 72076
Contact: Barbara Wilhelm, MD, Prof.     +49 70 71-29 8 48 98     barbara.wilhelm@stz-biomed.de    
Contact: Anusch Hekmat, Ph.D.     +49 7121 36403 ext 251     a.hekmat@retina-implant.de    
Sub-Investigator: Helmut Sachs, MD, PD            
Hungary
Miklos Resch, MD, PhD Recruiting
Budapest, Hungary, 1083
Contact: Akos Kusnyerik, MD     +36 20 922 00 04     kusnyerik@yahoo.com    
Principal Investigator: János Németh, MD, PhD, DSc            
Italy
Stanislao Rizzo, MD Recruiting
Pisa, Italy, 56126
Contact: Emanuele Di Bartolo, MD     +39 50 992175     emadibar@tin.it    
United Kingdom
Timothy L Jackson, MB.ChB, PhD, FRCOphth Recruiting
London, United Kingdom, SE5 9RS
Contact: Barbara Kolator     +44 20 3299 1297     Barbara.Kolator@kch.nhs.uk    
Robert MacLaren, MD, Prof., DPhil DipEd FRCOphth FRCS Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Robert MacLaren, MD     +44 1865 234782     robert.maclaren@eye.ox.ac.uk    
Contact: Susan Downes, MD         susan.downes@orh.nhs.uk    
Sub-Investigator: Sher Aslam, MD            
Sponsors and Collaborators
Retina Implant AG
Investigators
Study Chair: Eberhart Zrenner, Prof. MD Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen, Germany
Principal Investigator: Karl-Ulrich Bartz-Schmidt, Prof. MD University Eye Hospital Tuebingen, Germany
Principal Investigator: Claus Eckardt, Prof. MD Staedtische Kliniken Frankfurt a. M. -Hoechst, Germany
Principal Investigator: Timothy L Jackson, PhD FRCOphth King's College Hospital NHS Trust
Principal Investigator: János Németh, Prof. MD PhD Department of Ophthalmology Semmelweis University Budapest
Principal Investigator: Robert E MacLaren, Prof. DPhil Department of Ophthalmology, John Radcliffe Hospital, Oxford, UK
Principal Investigator: Stanislao Rizzo, MD Chairman U.O.Chirurgia Oftalmica Santa Chiara Hospital, Azienda Ospedaliero Universitaria Pisana, Italy
Principal Investigator: Johann Roider, Prof. MD University Eye Hospital, Kiel, Germany
Principal Investigator: Helmut Sachs, PD, MD Eye Hospital Dresden-Friedrichstadt, Germany
  More Information

No publications provided by Retina Implant AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Retina Implant AG
ClinicalTrials.gov Identifier: NCT01024803     History of Changes
Other Study ID Numbers: RI-MC-CT-2009
Study First Received: November 26, 2009
Last Updated: December 19, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Retina Implant AG:
Retina implant, Subretinal
Legal blindness
Genetic Diseases, Inborn
Eye Diseases
Retinitis Pigmentosa
 Retinitis
Retinal Degeneration
Eye Diseases, Hereditary
Retinal Diseases

Additional relevant MeSH terms:
Retinal Degeneration
Retinal Diseases
Retinitis
Retinitis Pigmentosa
 Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 22, 2013