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Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515814
First Posted: August 14, 2007
Last Update Posted: June 9, 2011
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.
Information provided by:
Retina Implant AG
  Purpose
The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.

Condition Intervention
Retinitis Pigmentosa Device: Retina implant is surgically placed into subretinal position

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Open Pilot Study With Functional Placebo-control to Evaluate the Efficacy and Tolerability/Safety of a Subretinal Implant in Blind Patients in Accordance With ICH/GCP Guidelines

Resource links provided by NLM:


Further study details as provided by Retina Implant AG:

Primary Outcome Measures:
  • Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY) [ Time Frame: within implantation period ]
  • Patient treatment shows acceptable results (i.e. SAFETY) [ Time Frame: within implantation period ]

Secondary Outcome Measures:
  • Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY) [ Time Frame: within implantation period ]
  • Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY) [ Time Frame: within implantation period ]

Estimated Enrollment: 15
Study Start Date: September 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1, 2
During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active.
Device: Retina implant is surgically placed into subretinal position
Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation & mobility.
Other Names:
  • Retina Implant, subretinal implant, vision prosthesis,
  • medical device for restoration of vision

Detailed Description:
Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hereditary retinal degeneration of the outer retinal layers with the retinal vessels still being perfused and pigments of mild to moderate density
  • Blindness (at least monocular) or visual functions not appropriate for navigation/orientation
  • Period of appropriate visual functions > 12 years / lifetime
  • Visual acuity ≥ 0,05 in earlier life
  • Electrically Evoked Phosphenes provide evidence of inner-retinal function.
  • willing and able to give written informed consent

Exclusion Criteria:

  • Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment)
  • Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases)
  • Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression )
  • Retina detected as too thin (< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT).
  • 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 clinical trial within the past 30 days
  Contacts and Locations
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): NCT00515814


Locations
Germany
Eye Hospital Dresden-Friedrichstadt
Dresden, Germany, 01067
University Eye Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
Retina Implant AG
Investigators
Principal Investigator: Eberhart - Zrenner, Prof.Dr.med. University Eye Hospital Tuebingen, Germany
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eberhart Zrenner / Prof. MD, Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen
ClinicalTrials.gov Identifier: NCT00515814     History of Changes
Other Study ID Numbers: RI-PT-2005
Retina Implant Project
First Submitted: August 13, 2007
First Posted: August 14, 2007
Last Update Posted: June 9, 2011
Last Verified: June 2011

Keywords provided by Retina Implant AG:
Legal blindness
Retinopathy pigmentosa
Hereditary condition
Photo-receptor degeneration
Retina implant
Subretinal implant

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