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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

November 26, 2009
December 19, 2011
December 2009
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01024803 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Retinitis Pigmentosa
  • Retinal Degeneration
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
Not Provided
Kusnyerik A, Greppmaier U, Wilke R, Gekeler F, Wilhelm B, Sachs HG, Bartz-Schmidt KU, Klose U, Stingl K, Resch MD, Hekmat A, Bruckmann A, Karacs K, Nemeth J, Suveges I, Zrenner E. Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Invest Ophthalmol Vis Sci. 2012 Jun 20;53(7):3748-55. Print 2012 Jun.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 78 Years
No
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
Germany,   Hungary,   Italy,   United Kingdom
 
NCT01024803
RI-MC-CT-2009
Yes
Retina Implant AG
Retina Implant AG
Not Provided
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
Retina Implant AG
December 2011

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