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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Retina Implant AG
ClinicalTrials.gov Identifier:
NCT01497379
First received: December 15, 2011
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Retinal Degeneration,
Retinitis Pigmentosa
Procedure: surgical implantation of subretinal device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Retina Implant AG:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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

  • Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Patient long term safety:

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

  • Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 5
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intra-individual implant ON
intra-individual implant activation
Procedure: surgical implantation of subretinal device
surgical implantation of subretinal device
Other Name: Retinal implant, subretinal implant
Placebo Comparator: intra-individual implant OFF
intra-individual implant deactivation
Procedure: surgical implantation of subretinal device
intra-individual implant OFF
Other Name: Retinal implant, subretinal implant

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497379

Locations
Hong Kong
Ophthalmology Eye Institute, University of Hong Kong
Hong Kong, Cyberport, Hong Kong, 100
Sponsors and Collaborators
Retina Implant AG
Investigators
Principal Investigator: David Wong, Prof., MD Chair Professor in Ophthalmology Eye Institute
  More Information

No publications provided

Responsible Party: Retina Implant AG
ClinicalTrials.gov Identifier: NCT01497379     History of Changes
Other Study ID Numbers: HKCTR-1198, RI-MC-CT-2009
Study First Received: December 15, 2011
Last Updated: April 28, 2014
Health Authority: Hong Kong: Hospital Authority Hong Kong

Keywords provided by Retina Implant AG:
Hereditary retinal
degeneration outer
retinal layers,
photoreceptor rods cones,
Retinitis pigmentosa,
blindness,
reading ability,
retina implant,
subretinal

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Degeneration
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014