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

Condition(s) targeted: Retinitis Pigmentosa

Intervention: Subretinal implant (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Retina Implant AG

Official(s) and/or principal investigator(s):
Eberhart - Zrenner, Prof.Dr.med., Principal Investigator, Affiliation: University Eye Hospital Tuebingen, Germany

Overall contact:
Barbara - Wilhelm, PD Dr.med., Phone: 49-7071-298-4898, Email: barbara.wilhelm@stz-biomed.de

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.

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 design: Treatment, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Activities of Daily Living and Orientation

Safety

Secondary outcome:

Vision performance via Basic Grating Acuity Test

Vision performance via Basic Location & Motion Test

Vision performance via Freiburg Acuity & Contrast Test

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.

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

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

- willing and able to give written informed consent

Exclusion Criteria:

- Any other ophthalmologic diseases with relevant effects upon visual function (e. g.

glaucoma, optic neuropathy, trauma, retinal detachment)

- Systemic diseases that might imply considerable risks with regard to the surgical

interventions and anesthesia (e. g. cardiovascular diseases, severe metabolic diseases)

- Neurological and/or psychiatric diseases (e. g. M. Parkinson, epilepsy, depression )

- Known hypersensitivity to any of the ingredients of the study device

- 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

Barbara - Wilhelm, PD Dr.med., Phone: 49-7071-298-4898, Email: barbara.wilhelm@stz-biomed.de

University Eye Hospital Tuebingen, Tuebingen 72076, Germany; Recruiting
Karl-Ulrich - Bartz-Schmidt, Prof.Dr.med., Principal Investigator
Helmut - Sachs, PD Dr. med., Sub-Investigator

University Eye Hospital Regensburg, Regensburg 93042, Germany; Recruiting
Helmut - Sachs, PD Dr.med., Principal Investigator

patient self-help, support and advocacy organization

Starting date: September 2005
Ending date: December 2008
Last updated: April 23, 2008