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

Primary Purpose

Retinal Degeneration, Retinitis Pigmentosa

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

surgical implantation of subretinal device

About this trial

This is an interventional treatment trial for Retinal Degeneration focused on measuring Hereditary retinal, degeneration outer, retinal layers, photoreceptor rods cones, Retinitis pigmentosa, blindness, reading ability, retina implant, subretinal

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Ophthalmology Eye Institute, University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intra-individual implant ON

intra-individual implant OFF

Arm Description

intra-individual implant activation

intra-individual implant deactivation

Outcomes

Primary Outcome Measures

Safety

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

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

Patient long term safety: stability of implant function stability of body structure & function related to implant system

Efficacy

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

Full Information

NCT ID

NCT01497379

First Posted

December 15, 2011

Last Updated

March 28, 2017

Sponsor

Retina Implant AG

1. Study Identification

Unique Protocol Identification Number

NCT01497379

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Retina Implant AG

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Degeneration, Retinitis Pigmentosa

Keywords

Hereditary retinal, degeneration outer, retinal layers, photoreceptor rods cones, Retinitis pigmentosa, blindness, reading ability, retina implant, subretinal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intra-individual implant ON

Arm Type

Experimental

Arm Description

intra-individual implant activation

Arm Title

intra-individual implant OFF

Arm Type

Placebo Comparator

Arm Description

intra-individual implant deactivation

Intervention Type

Procedure

Intervention Name(s)

surgical implantation of subretinal device

Other Intervention Name(s)

Retinal implant, subretinal implant

Intervention Description

surgical implantation of subretinal device

Intervention Type

Procedure

Intervention Name(s)

surgical implantation of subretinal device

Other Intervention Name(s)

Retinal implant, subretinal implant

Intervention Description

intra-individual implant OFF

Primary Outcome Measure Information:

Title

Safety

Description

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

Time Frame

1 year

Title

Efficacy

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Safety

Description

Patient long term safety: stability of implant function stability of body structure & function related to implant system

Time Frame

1 year

Title

Efficacy

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Wong, Prof., MD

Organizational Affiliation

Chair Professor in Ophthalmology Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmology Eye Institute, University of Hong Kong

City

Hong Kong

State/Province

Cyberport

ZIP/Postal Code

100

Country

Hong Kong

12. IPD Sharing Statement

Citations:

PubMed Identifier

25812924

Citation

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.

Results Reference

result

Links:

URL

http://www.hkclinicaltrials.com/

Description

Hong Kong clinical trials registry

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

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