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

Sponsor:	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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome retinitis pigmentosa X-linked juvenile retinoschisis Help Me Understand Genetics

U.S. FDA Resources

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
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

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

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:

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

No publications provided by Retina Implant AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wilke R, Gabel VP, Sachs H, Bartz Schmidt KU, Gekeler F, Besch D, Szurman P, Stett A, Wilhelm B, Peters T, Harscher A, Greppmaier U, Kibbel S, Benav H, Bruckmann A, Stingl K, Kusnyerik A, Zrenner E. Spatial resolution and perception of patterns mediated by a subretinal 16-electrode array in patients blinded by hereditary retinal dystrophies. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5995-6003. Print 2011 Jul.

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
Study First Received:	August 13, 2007
Last Updated:	June 8, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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
Retinal Diseases
Eye Diseases

Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 09, 2012