Safety and Efficacy of Subretinal Implants for Partial Restoration of Visio... | Not Recruiting
Safety and Efficacy of Subretinal I... | Not Recruiting
Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

Trial Source

Location not identified by Google services

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

Medical Conditions
  • Retinitis Pigmentosa
  • Retinal Degeneration
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT01024803
Primary Trial ID Number

We need your help to advance medical research

You can help accelerate the discovery of cures of medical conditions by signing up and creating a profile. By doing so you can register your interest in clinical trials and researchers will be able to get in touch about trials that are suitable for you.

This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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)
Stingl K, Bartz-Schmidt KU, Besch D, Chee CK, Cottriall CL, Gekeler F, Groppe M, Jackson TL, MacLaren RE, Koitschev A, Kusnyerik A, Neffendorf J, Nemeth J, Naeem MA, Peters T, Ramsden JD, Sachs H, Simpson A, Singh MS, Wilhelm B, Wong D, Zrenner E. Subretinal Visual Implant Alpha IMS--Clinical trial interim report. Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23.; 25812924; Kitiratschky VB, Stingl K, Wilhelm B, Peters T, Besch D, Sachs H, Gekeler F, Bartz-Schmidt KU, Zrenner E. Safety evaluation of "retina implant alpha IMS"--a prospective clinical trial. Graefes Arch Clin Exp Ophthalmol. 2015 Mar;253(3):381-7. doi: 10.1007/s00417-014-2797-x. Epub 2014 Sep 16.; 25219982; Stingl K, Bartz-Schmidt KU, Gekeler F, Kusnyerik A, Sachs H, Zrenner E. Functional outcome in subretinal electronic implants depends on foveal eccentricity. Invest Ophthalmol Vis Sci. 2013 Nov 19;54(12):7658-65. doi: 10.1167/iovs.13-12835.; 24150759
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
King's College Hospital
London
SE5 9RS
Oxford
OX3 9DU
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, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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

May 2017

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

26 Nov 2009

Last Updated

06 Apr 2016