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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2009

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 1, 2
    • During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Patient treatment shows acceptable results (i.e. SAFETY)
    • Time Frame: within implantation period

Secondary Measures

  • 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
  • Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)
    • Time Frame: within implantation period

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 78 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Retina Implant AG
  • Provider of Information About this Clinical Study
    • Eberhart Zrenner / Prof. MD, Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen
  • Overall Official(s)
    • Eberhart – Zrenner, Prof.Dr.med., Principal Investigator, University Eye Hospital Tuebingen, Germany

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.