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

Primary Purpose

Retinitis Pigmentosa, Retinal Degeneration

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retina implant, Subretinal, Legal blindness, Genetic Diseases, Inborn, Eye Diseases, Retinitis Pigmentosa, Retinitis, Retinal Degeneration, Eye Diseases, Hereditary, Retinal Diseases

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.
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.

Sites / Locations

Helmut Sachs, MD, PD
Johann Roider, MD, Prof.
Karl-Ulrich Bartz-Schmidt, MD, Prof.
Miklos Resch, MD, PhD
Timothy L Jackson, MB.ChB, PhD, FRCOphth
Robert MacLaren, MD, Prof., DPhil DipEd FRCOphth FRCS

Outcomes

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.

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.

Patient long term safety and stability of implant function

Full Information

NCT ID

NCT01024803

First Posted

November 26, 2009

Last Updated

September 3, 2018

Sponsor

Retina Implant AG

1. Study Identification

Unique Protocol Identification Number

NCT01024803

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2018 (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 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.

6. Conditions and Keywords

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

Retinitis Pigmentosa, Retinal Degeneration

Keywords

Retina implant, Subretinal, Legal blindness, Genetic Diseases, Inborn, Eye Diseases, Retinitis Pigmentosa, Retinitis, Retinal Degeneration, Eye Diseases, Hereditary, Retinal Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye

Other Intervention Name(s)

retinal implant, bionic eye, artificial vision, artificial eye, restoration of vision, eye chip, vision prosthesis, eye implant, retinal prosthesis

Intervention Description

Surgical implantation of medical device named "Retina Implant" into eye to restore vision partially. Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL.

Primary Outcome Measure Information:

Title

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.

Time Frame

every 3 months for a period of one year

Secondary Outcome Measure Information:

Title

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.

Time Frame

every 3 months for a period of one year

Title

Patient long term safety and stability of implant function

Time Frame

every 3 months for a period of one 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. 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.

Overall Study Officials: