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

Retinitis Pigmentosa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515814
• Other study ID #: RI-PT-2005
• Secondary ID: Retina Implant P
• Status: Completed
• Phase: N/A
• First received: August 13, 2007
• Last updated: June 8, 2011
• Start date: September 2005
• Est. completion date: December 2009

Study information

• Verified date: June 2011
• Source: Retina Implant AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinitis Pigmentosa

Intervention

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.

Locations

Country	Name	City	State
Germany	Eye Hospital Dresden-Friedrichstadt	Dresden
Germany	University Eye Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
Retina Implant AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Patient treatment shows acceptable results (i.e. SAFETY)		within implantation period	Yes
Secondary	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	Yes
Secondary	Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)		within implantation period	Yes

External Links

•   patient self-help, support and advocacy organization