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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01024803
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Retina Implant AG

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Retinitis Pigmentosa Retinal Degeneration Device: Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : December 2009
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2018

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Arms and Interventions
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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

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Patient long term safety and stability of implant function [ Time Frame: every 3 months for a period of one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024803


Locations
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Germany
Helmut Sachs, MD, PD
Dresden, Germany, 01067
Johann Roider, MD, Prof.
Kiel, Germany, 24105
Karl-Ulrich Bartz-Schmidt, MD, Prof.
Tuebingen, Germany, 72076
Hungary
Miklos Resch, MD, PhD
Budapest, Hungary, 1083
United Kingdom
Timothy L Jackson, MB.ChB, PhD, FRCOphth
London, United Kingdom, SE5 9RS
Robert MacLaren, MD, Prof., DPhil DipEd FRCOphth FRCS
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Retina Implant AG
Investigators
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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: 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: Johann Roider, Prof. MD University Eye Hospital, Kiel, Germany
Principal Investigator: Helmut Sachs, PD, MD Eye Hospital Dresden-Friedrichstadt, Germany
More Information
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Publications of Results:

Other Publications:

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

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Responsible Party: Retina Implant AG
ClinicalTrials.gov Identifier: NCT01024803    
Other Study ID Numbers: RI-MC-CT-2009
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
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:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Retinal Degeneration
 Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn