Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

September 3, 2018 updated by: Retina Implant AG

Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Patients With Degenerative Retinal Diseases

Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight.

Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01067
        • Helmut Sachs, MD, PD
      • Kiel, Germany, 24105
        • Johann Roider, MD, Prof.
      • Tuebingen, Germany, 72076
        • Karl-Ulrich Bartz-Schmidt, MD, Prof.
  • Hungary
      • Budapest, Hungary, 1083
        • Miklos Resch, MD, PhD
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Timothy L Jackson, MB.ChB, PhD, FRCOphth
      • Oxford, United Kingdom, OX3 9DU
        • Robert MacLaren, MD, Prof., DPhil DipEd FRCOphth FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods & cones.
  • Pseudophakia
  • Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
  • Age between 18 and 78 years.
  • Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation.
  • Ability to read normal print in earlier life, optically corrected without magnifying glass.
  • Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year for Module-2.

Exclusion Criteria:

  • Period of appropriate visual functions approx. 12 years / lifetime.
  • Optical Coherence Tomography (OCT) shows significant retina edema &/or scar tissue within target region for implant.
  • Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT).
  • Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP).
  • Heavy clumped pigmentation at posterior pole
  • Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment).
  • Amblyopia reported earlier in life on eye to be implanted
  • Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases).
  • Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression).
  • Hyperthyroidism or hypersensitivity to iodine
  • 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 interventional clinical trial within the past 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof.
Time Frame: every 3 months for a period of one year
every 3 months for a period of one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity/light-perception and/or object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT/BaLM/BaGA/VFQ-25 or a combination thereof.
Time Frame: every 3 months for a period of one year
every 3 months for a period of one year
Patient long term safety and stability of implant function
Time Frame: every 3 months for a period of one year
every 3 months for a period of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Retina Implant AG

Investigators

  • Principal Investigator: Timothy L Jackson, PhD FRCOphth, King's College Hospital NHS Trust
  • Study Chair: Eberhart Zrenner, Prof. MD, Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen, Germany
  • Principal Investigator: Karl-Ulrich Bartz-Schmidt, Prof. MD, University Eye Hospital Tuebingen, Germany
  • Principal Investigator: János Németh, Prof. MD PhD, Department of Ophthalmology Semmelweis University Budapest
  • Principal Investigator: Robert E MacLaren, Prof. DPhil, Department of Ophthalmology, John Radcliffe Hospital, Oxford, UK
  • Principal Investigator: Johann Roider, Prof. MD, University Eye Hospital, Kiel, Germany
  • Principal Investigator: Helmut Sachs, PD, MD, Eye Hospital Dresden-Friedrichstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

November 26, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RI-MC-CT-2009 (Clinicaltrials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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