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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Retinitis Pigmentosa
  • Retinal Degeneration
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruiting
Recruitment Status
NCT01024803
Primary Trial ID Number
Summary
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.
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Device : Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye
Intervention Type
See Interventions above
Primary Outcome Measures
  • 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.; every 3 months for a period of one year
Secondary Outcome Measures
  • 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.; every 3 months for a period of one year; Patient long term safety and stability of implant function; every 3 months for a period of one year
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - 78 Years
Who Can Participate
Patients
Number of Participants
45
Participant Inclusion 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.
  • - 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
University of Oxford
Oxford
Oxfordshire
OX3 9DU
King's College Hospital
London
England
SE5 9RS
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Germany, Hungary, Italy, United Kingdom
Scientific Title
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
RI-MC-CT-2009
Sponsor(s)
Retina Implant AG
Key Dates

Recruitment Start Date

Dec 2009

Recruitment End Date

Dec 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

26 Nov 2009

Last Updated

11 Jul 2014