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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Retina Implant AG Identifier:
First received: November 26, 2009
Last updated: October 26, 2015
Last verified: October 2015

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:

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: April 2017
Estimated Primary Completion Date: February 2016 (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

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

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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Please refer to this study by its identifier: NCT01024803

Helmut Sachs, MD, PD
Dresden, Germany, 01067
Johann Roider, MD, Prof.
Kiel, Germany, 24105
Karl-Ulrich Bartz-Schmidt, MD, Prof.
Tuebingen, Germany, 72076
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
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

No publications provided by Retina Implant AG

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Retina Implant AG Identifier: NCT01024803     History of Changes
Other Study ID Numbers: RI-MC-CT-2009
Study First Received: November 26, 2009
Last Updated: October 26, 2015
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
Retinal Degeneration
Eye Diseases, Hereditary
Retinal Diseases

Additional relevant MeSH terms:
Retinal Degeneration
Retinal Diseases
Retinitis Pigmentosa
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Retinal Dystrophies processed this record on November 27, 2015