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Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

Primary Purpose

Retinitis Pigmentosa

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Retina implant is surgically placed into subretinal position

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Legal blindness, Retinopathy pigmentosa, Hereditary condition, Photo-receptor degeneration, Retina implant, Subretinal implant

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 with the retinal vessels still being perfused and pigments of mild to moderate density
Blindness (at least monocular) or visual functions not appropriate for navigation/orientation
Period of appropriate visual functions > 12 years / lifetime
Visual acuity ≥ 0,05 in earlier life
Electrically Evoked Phosphenes provide evidence of inner-retinal function.
willing and able to give written informed consent

Exclusion Criteria:

Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment)
Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases)
Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression )
Retina detected as too thin (< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT).
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 clinical trial within the past 30 days

Sites / Locations

Eye Hospital Dresden-Friedrichstadt
University Eye Hospital Tuebingen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1, 2

Arm Description

During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active.

Outcomes

Primary Outcome Measures

Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY)

Patient treatment shows acceptable results (i.e. SAFETY)

Secondary Outcome Measures

Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY)

Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)

Full Information

NCT ID

NCT00515814

First Posted

August 13, 2007

Last Updated

June 8, 2011

Sponsor

Retina Implant AG

1. Study Identification

Unique Protocol Identification Number

NCT00515814

Brief Title

Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

Official Title

A Prospective Open Pilot Study With Functional Placebo-control to Evaluate the Efficacy and Tolerability/Safety of a Subretinal Implant in Blind Patients in Accordance With ICH/GCP Guidelines

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Retina Implant AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.

Detailed Description

Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.

6. Conditions and Keywords

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

Retinitis Pigmentosa

Keywords

Legal blindness, Retinopathy pigmentosa, Hereditary condition, Photo-receptor degeneration, Retina implant, Subretinal implant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1, 2

Arm Type

Experimental

Arm Description

During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active.

Intervention Type

Device

Intervention Name(s)

Retina implant is surgically placed into subretinal position

Other Intervention Name(s)

Retina Implant, subretinal implant, vision prosthesis,, medical device for restoration of vision

Intervention Description

Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation & mobility.

Primary Outcome Measure Information:

Title

Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY)

Time Frame

within implantation period

Title

Patient treatment shows acceptable results (i.e. SAFETY)

Time Frame

within implantation period

Secondary Outcome Measure Information:

Title

Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY)

Time Frame

within implantation period

Title

Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY)

Time Frame

within implantation period

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 with the retinal vessels still being perfused and pigments of mild to moderate density Blindness (at least monocular) or visual functions not appropriate for navigation/orientation Period of appropriate visual functions > 12 years / lifetime Visual acuity ≥ 0,05 in earlier life Electrically Evoked Phosphenes provide evidence of inner-retinal function. willing and able to give written informed consent Exclusion Criteria: Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment) Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases) Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression ) Retina detected as too thin (< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT). 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 clinical trial within the past 30 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eberhart - Zrenner, Prof.Dr.med.

Organizational Affiliation

University Eye Hospital Tuebingen, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eye Hospital Dresden-Friedrichstadt

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

University Eye Hospital Tuebingen

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24150759

Citation

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.

Results Reference

derived

PubMed Identifier

22562517

Citation

Kusnyerik A, Greppmaier U, Wilke R, Gekeler F, Wilhelm B, Sachs HG, Bartz-Schmidt KU, Klose U, Stingl K, Resch MD, Hekmat A, Bruckmann A, Karacs K, Nemeth J, Suveges I, Zrenner E. Positioning of electronic subretinal implants in blind retinitis pigmentosa patients through multimodal assessment of retinal structures. Invest Ophthalmol Vis Sci. 2012 Jun 20;53(7):3748-55. doi: 10.1167/iovs.11-9409.

Results Reference

derived

PubMed Identifier

21693599

Citation

Wilke R, Gabel VP, Sachs H, Bartz Schmidt KU, Gekeler F, Besch D, Szurman P, Stett A, Wilhelm B, Peters T, Harscher A, Greppmaier U, Kibbel S, Benav H, Bruckmann A, Stingl K, Kusnyerik A, Zrenner E. Spatial resolution and perception of patterns mediated by a subretinal 16-electrode array in patients blinded by hereditary retinal dystrophies. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5995-6003. doi: 10.1167/iovs.10-6946.

Results Reference

derived

Links:

URL

http://www.pro-retina.de

Description

patient self-help, support and advocacy organization

Learn more about this trial

Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

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