Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 15, 2011
April 28, 2014
October 2011
January 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01497379 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Retinal Degeneration,
  • Retinitis Pigmentosa
  • Procedure: surgical implantation of subretinal device
    surgical implantation of subretinal device
    Other Name: Retinal implant, subretinal implant
  • Procedure: surgical implantation of subretinal device
    intra-individual implant OFF
    Other Name: Retinal implant, subretinal implant
  • Experimental: intra-individual implant ON
    intra-individual implant activation
    Intervention: Procedure: surgical implantation of subretinal device
  • Placebo Comparator: intra-individual implant OFF
    intra-individual implant deactivation
    Intervention: Procedure: surgical implantation of subretinal device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
5
December 2015
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT01497379
HKCTR-1198, RI-MC-CT-2009
Yes
Retina Implant AG
Retina Implant AG
Not Provided
Principal Investigator: David Wong, Prof., MD Chair Professor in Ophthalmology Eye Institute
Retina Implant AG
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP