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

Not Applicable

Completed

• Conditions: Retinitis Pigmentosa
• Interventions: Device: Retina implant is surgically placed into subretinal position

• Registration Number: NCT00515814
• Lead Sponsor: Retina Implant AG

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-14
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1, 2	Retina implant is surgically placed into subretinal position	During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active.

Primary Outcome Measures

Name	Time	Method
Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY)	within implantation period
Patient treatment shows acceptable results (i.e. SAFETY)	within implantation period

Secondary Outcome Measures

Name	Time	Method
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)	within implantation period
Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)	within implantation period

Trial Locations

Locations (2)

Eye Hospital Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

University Eye Hospital Tuebingen; 🇩🇪 Tuebingen, Germany