Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-Receptors - Full Text View

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: Subretinal implant

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome X-linked juvenile retinoschisis

U.S. FDA Resources

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

Further study details as provided by Retina Implant AG:

Primary Outcome Measures:

Activities of Daily Living and Orientation [ Time Frame: within implantation period ] [ Designated as safety issue: Yes ]
Safety [ Time Frame: within implantation period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Vision performance via Basic Grating Acuity Test [ Time Frame: within implantation period ] [ Designated as safety issue: Yes ]
Vision performance via Basic Location & Motion Test [ Time Frame: within implantation period ] [ Designated as safety issue: Yes ]
Vision performance via Freiburg Acuity & Contrast Test [ Time Frame: within implantation period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	September 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 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: Subretinal implant Subretinal implant is either in On or in OFF condition during measurement/test periods.

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
willing and able to give written informed consent

Exclusion Criteria:

Any other ophthalmologic diseases with relevant effects upon visual function (e.g. glaucoma, optic neuropathy, trauma, retinal detachment)
Systemic diseases that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases)
Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression )
Known hypersensitivity to any of the ingredients of the study device
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

Locations

Germany
University Eye Hospital Tuebingen
Tuebingen, Germany, 72076
Eye Hospital Dresden-Friedrichstadt
Dresden, Germany, 01067

Sponsors and Collaborators

Retina Implant AG

Investigators

Principal Investigator:

Eberhart - Zrenner, Prof.Dr.med.

University Eye Hospital Tuebingen, Germany

More Information

patient self-help, support and advocacy organization This link exits the ClinicalTrials.gov site

Responsible Party:	Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen ( Eberhart Zrenner / Prof. Dr. med. )
Study ID Numbers:	RI-PT-2005, Retina Implant Project
Study First Received:	August 13, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00515814
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: Regierungspraesidium Tuebingen; Germany: Ethics Committee of Medical Faculty of University Hospital Tuebingen

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
Genetic Diseases, Inborn
Eye Diseases
Cone rod dystrophy
Retinitis Pigmentosa
Retinitis

Retinal Degeneration
Eye Diseases, Hereditary
Blindness
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 16, 2009