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OpenTrials
Completed

NCT Number: NCT01497379

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

Patients who are legally blind, caused by retinal degeneration of photoreceptor rods & cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.

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Key information

Conditions

Retinal Degeneration Blindness Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology Eye Institute, University of Hong Kong

Hong Kong, Cyberport, 100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (impaired light localization or worse).
  • 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

Exclusion criteria

  • Period of appropriate visual functions < 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.

Treatment and study plan

surgical implantation of subretinal device

Procedure

surgical implantation of subretinal device

Other names: Retinal implant, subretinal implant

Primary outcomes

  1. Safety

    Time frame: 1 year

    treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients

  2. Efficacy

    Time frame: 1 year

    Activities of Daily Living & Mobility are significantly improved with implant-ON versus OFF, as shown via tests:

    • Activities of Daily Living tasks or
    • Recognition tasks or
    • Mobility or
    • a combination of the above

Secondary outcomes

  1. Safety

    Time frame: 1 year

    Patient long term safety:

    • stability of implant function
    • stability of body structure & function related to implant system

  2. Efficacy

    Time frame: 1 year

    Visual Acuity / Light-perception and/or Object-recognition are significantly improved with implant-ON versus OFF as shown via:

    • FrACT or
    • BaLM or
    • Grating test (e.g. BaGA) and/or Quality of life
    • Quality of life (questionnaire) or
    • a combination of the above

Sponsors and collaborators

Lead sponsor

Retina Implant AG

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Dec 22, 2011
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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