Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors
This study has been completed.
Sponsor:
Retina Implant AG
Information provided by:
Retina Implant AG
ClinicalTrials.gov Identifier:
NCT00515814
First received: August 13, 2007
Last updated: June 8, 2011
Last verified: June 2011
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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
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:
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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:
No publications provided by Retina Implant AG
Additional 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 |
| 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 May 16, 2013