Clinical trial NCT00515814: Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: Legal blindness
Retinopathy pigmentosa
Hereditary condition
Photo-receptor degeneration
Retina implant
Subretinal implant
Lead sponsor: Retina Implant AG
Sponsor class: INDUSTRY
First posted: 2007-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
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)
timeFrame: within implantation period
measure: Patient treatment shows acceptable results (i.e. SAFETY)
timeFrame: within implantation period
Secondary outcomes:
measure: 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)
timeFrame: within implantation period
measure: Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)
timeFrame: within implantation period
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Eye Hospital Dresden-Friedrichstadt
city: Tuebingen
country: Germany
facility: University Eye Hospital Tuebingen
Study officials:
affiliation: University Eye Hospital Tuebingen, Germany
name: Eberhart - Zrenner, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stingl K, Bartz-Schmidt KU, Gekeler F, Kusnyerik A, Sachs H, Zrenner E. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. 2013 Nov 19;54(12):7658-65. doi: 10.1167/iovs.13-12835.
citation: Kusnyerik A, Greppmaier U, Wilke R, Gekeler F, Wilhelm B, Sachs HG, Bartz-Schmidt KU, Klose U, Stingl K, Resch MD, Hekmat A, Bruckmann A, Karacs K, Nemeth J, Suveges I, Zrenner E. Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Invest Ophthalmol Vis Sci. 2012 Jun 20;53(7):3748-55. doi: 10.1167/iovs.11-9409.
citation: 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. doi: 10.1167/iovs.10-6946.