| August 13, 2007 |
| June 3, 2009 |
| September 2005 |
| December 2009 (final data collection date for primary outcome measure) |
- 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 ]
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| Activities of Daily Living and Orientation [ Time Frame: within 4 months after surgical implantation ] |
| Complete list of historical versions of study NCT00515814 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Vision performance via Basic Grating Acuity, Basic Location & Motion Test, Freiburg Acuity & Contrast Test [ Time Frame: within 4 months after surgical implantation ] |
| |
| Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-Receptors |
| 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 |
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. |
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. |
| |
| Interventional |
| Treatment, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Retinitis Pigmentosa |
| Device: Retina implant is surgically placed into subretinal position |
| Experimental: During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active. |
| |
| |
| Recruiting |
| 15 |
| June 2010 |
| December 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 78 Years |
| No |
|
|
| Germany |
| |
| NCT00515814 |
| Eberhart Zrenner / Prof. MD, Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen |
| RI-PT-2005, Retina Implant Project |
| Retina Implant AG |
|
| Principal Investigator: |
Eberhart - Zrenner, Prof.Dr.med. |
University Eye Hospital Tuebingen, Germany |
|
|
| Retina Implant AG |
| June 2009 |