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

Sponsor

Retina Implant AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01497379

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Retinal Degeneration Retinitis Pigmentosa	Procedure: surgical implantation of subretinal device Procedure: surgical implantation of subretinal device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

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.

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intra-individual implant ON intra-individual implant activation	Procedure: surgical implantation of subretinal device surgical implantation of subretinal device Other Names: 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 Names: Retinal implant, subretinal implant

Arm

Intervention/Treatment

Experimental: intra-individual implant ON

intra-individual implant activation

Procedure: surgical implantation of subretinal device

surgical implantation of subretinal device

Other Names:

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 Names:

Retinal implant, subretinal implant

Outcome Measures

Primary Outcome Measures

Safety [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
Efficacy [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 Outcome Measures

Safety [1 year]
Patient long term safety: stability of implant function stability of body structure & function related to implant system
Efficacy [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.