Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE November 26, 2009
First Posted Date  ICMJE December 3, 2009
Last Update Posted Date September 5, 2018
Study Start Date  ICMJE December 2009
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
  • 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 ]
  • Patient long term safety and stability of implant function [ Time Frame: every 3 months for a period of one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Retinitis Pigmentosa
  • Retinal Degeneration
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2009)
45
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Hungary,   United Kingdom
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT01024803
Other Study ID Numbers  ICMJE RI-MC-CT-2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Retina Implant AG
Study Sponsor  ICMJE Retina Implant AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Retina Implant AG
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP