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Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-Receptors
This study is currently recruiting participants.
Verified by Retina Implant AG, June 2009
First Received: August 13, 2007   Last Updated: June 3, 2009   History of Changes
Sponsored by: Retina Implant AG
Information provided by: Retina Implant AG
ClinicalTrials.gov Identifier: NCT00515814
  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: Treatment, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
  • Patient treatment shows acceptable results (i.e. SAFETY) [ Time Frame: within implantation period ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY) [ Time Frame: within implantation period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: September 2005
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1, 2: Experimental
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.

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

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515814

Contacts
Contact: Barbara - Wilhelm, PD Dr.med. 49-7071-298-4898 barbara.wilhelm@stz-biomed.de
Contact: Anuschirawan - Hekmat, Dr.rer.nat. 49-7121-3640-3251 hekmat@retina-implant.de

Locations
Germany
University Eye Hospital Tuebingen Recruiting
Tuebingen, Germany, 72076
Principal Investigator: Karl-Ulrich - Bartz-Schmidt, Prof.Dr.med.            
Sub-Investigator: Helmut - Sachs, PD Dr. med.            
Eye Hospital Dresden-Friedrichstadt Recruiting
Dresden, Germany, 01067
Principal Investigator: Helmut - Sachs, PD Dr.med.            
Sponsors and Collaborators
Retina Implant AG
Investigators
Principal Investigator: Eberhart - Zrenner, Prof.Dr.med. University Eye Hospital Tuebingen, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen ( Eberhart Zrenner / Prof. MD )
Study ID Numbers: RI-PT-2005, Retina Implant Project
Study First Received: August 13, 2007
Last Updated: June 3, 2009
ClinicalTrials.gov Identifier: NCT00515814     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Pigmentary Retinopathy
Cone Rod Dystrophy
Genetic Diseases, Inborn
Eye Diseases
Retinitis Pigmentosa
Retinitis
Retinal Degeneration
Eye Diseases, Hereditary
Blindness
Retinal Diseases

Additional relevant MeSH terms:
Genetic Diseases, Inborn
Eye Diseases
Retinitis Pigmentosa
Retinitis
Retinal Degeneration
Eye Diseases, Hereditary
Retinal Diseases

ClinicalTrials.gov processed this record on September 04, 2009