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Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Primary Purpose

Retinal Degeneration, Inherited Retinal Dystrophy Primarily Involving Sensory Retina

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

RETINA IMPLANT Alpha AMS

About this trial

This is an interventional treatment trial for Retinal Degeneration focused on measuring Retinal Degeneration, Artificial Vision, Retinal Prosthesis, Subretinal Implant, Inherited Retinal Dystrophy, Vision Restoration, Bionic Eye, Bionic Vision, Retinitis Pigmentosa, Artificial Retina, Retina Implant, Cone-Rod Dystrophy, Choroideremia, Retinopathia Pigmentosa

Eligibility Criteria

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

Inclusion Criteria:

Age 18 to 78
Willing and able to give written informed consent
Hereditary retinal degeneration of the outer retinal layer i.e. photoreceptors (rods & cones)
Pseudophakia or aphakia in the eye to be implanted
Retinal vessels with remaining perfusion, despite pathological condition
Layering of inner retina in the central region present, as shown by Optical Coherence Tomography (OCT)
Thickness of the retina sufficient for subretinal surgery as shown by OCT
Inner retina still functional (proven e.g. by light perception or electrically evoked phosphenes (EEP))
Blindness in both eyes, (no light perception or light perception only)
Visual acuity sufficient for reading normal print in earlier life, optically corrected
Period of appropriate visual functions at least 12 years / lifetime
Willing and able to perform study assessments and training during the full time period of 12 months
Motivation to get the best possible results through training and realistic expectations about these as assessed in screening interview

Exclusion Criteria:

OCT shows significant retina edema and/or scar tissue within target region for implant
Heavy clumped pigmentation at posterior pole or on the planned route of the implantation
atrophy of optic nerve or ganglion cells degeneration
Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment)
Deep amblyopia reported earlier in life on eye to be implanted
Systemic conditions that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular/pulmonary diseases, severe metabolic diseases)
Acute and severe neurological and/or psychiatric diseases
Hyperthyroidism or hypersensitivity to iodine
Hypersensitivity to fluorescent dye
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 study within the past 30 days

Sites / Locations

Clinique Saint Jean
Centre Hospitalier Universitaire La Milétrie de Poitiers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RETINA IMPLANT Alpha AMS

Arm Description

All participants receive the subretinal device RETINA IMPLANT Alpha AMS

Outcomes

Primary Outcome Measures

Change in functional vision

Instrumental Activities of Daily Living assessed at baseline (prior to implantation) versus one year after implantation

Secondary Outcome Measures

Vision Related Quality of Life - Questionnaire

A validated patient reported outcome questionnaire, IVI-VLV, assessed at baseline versus one year after implantation

Visual Function - Questionnaire

A validated patient reported outcome questionnaire, ULV-VFQ, assessed at baseline versus one year after implantation

Adverse Events

Number, nature and severity of device-related and implantation-related adverse events

Measure of implant-mediated visual function

Computer test assessed with implant on versus off

Full Information

NCT ID

NCT03561922

First Posted

May 17, 2018

Last Updated

April 17, 2019

Sponsor

Retina Implant AG

1. Study Identification

Unique Protocol Identification Number

NCT03561922

Brief Title

Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Official Title

Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

Manufacturer of the investigational device has ceased all business activities

Study Start Date

September 4, 2018 (Actual)

Primary Completion Date

April 5, 2019 (Actual)

Study Completion Date

April 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Retina Implant AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.

Detailed Description

This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life. In addition, the study will provide additional information about the safety and efficacy of the CE-certified RETINA IMPLANT Alpha AMS. In several studies it has been shown that patients who received this subretinal implant regain visual function to a certain extent and that its use is safe. So far, all assessments of patients with the RETINA IMPLANT Alpha AMS have been done in a controlled environment within the scope of interventional studies where the benefit in daily life has been assessed anecdotally only. Currently, there is no standard method available for an objective assessment of the impact of such devices in daily life of these patients. Hence, the aim of this study is to further assess the impact in daily life with a combination of already validated and newly developed assessments and questionnaires. This study adheres to the tenets of the Declaration of Helsinki.

6. Conditions and Keywords

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

Retinal Degeneration, Inherited Retinal Dystrophy Primarily Involving Sensory Retina

Keywords

Retinal Degeneration, Artificial Vision, Retinal Prosthesis, Subretinal Implant, Inherited Retinal Dystrophy, Vision Restoration, Bionic Eye, Bionic Vision, Retinitis Pigmentosa, Artificial Retina, Retina Implant, Cone-Rod Dystrophy, Choroideremia, Retinopathia Pigmentosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RETINA IMPLANT Alpha AMS

Arm Type

Experimental

Arm Description

All participants receive the subretinal device RETINA IMPLANT Alpha AMS

Intervention Type

Device

Intervention Name(s)

RETINA IMPLANT Alpha AMS

Intervention Description

Implantation of the subretinal RETINA IMPLANT Alpha AMS

Primary Outcome Measure Information:

Title

Change in functional vision

Description

Instrumental Activities of Daily Living assessed at baseline (prior to implantation) versus one year after implantation

Time Frame

baseline vs. 12 months after implantation

Secondary Outcome Measure Information:

Title

Vision Related Quality of Life - Questionnaire

Description

A validated patient reported outcome questionnaire, IVI-VLV, assessed at baseline versus one year after implantation

Time Frame

at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)

Title

Visual Function - Questionnaire

Description

A validated patient reported outcome questionnaire, ULV-VFQ, assessed at baseline versus one year after implantation

Time Frame

at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)

Title

Adverse Events

Description

Number, nature and severity of device-related and implantation-related adverse events

Time Frame

2 years

Title

Measure of implant-mediated visual function

Description

Computer test assessed with implant on versus off

Time Frame

2 years

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: Age 18 to 78 Willing and able to give written informed consent Hereditary retinal degeneration of the outer retinal layer i.e. photoreceptors (rods & cones) Pseudophakia or aphakia in the eye to be implanted Retinal vessels with remaining perfusion, despite pathological condition Layering of inner retina in the central region present, as shown by Optical Coherence Tomography (OCT) Thickness of the retina sufficient for subretinal surgery as shown by OCT Inner retina still functional (proven e.g. by light perception or electrically evoked phosphenes (EEP)) Blindness in both eyes, (no light perception or light perception only) Visual acuity sufficient for reading normal print in earlier life, optically corrected Period of appropriate visual functions at least 12 years / lifetime Willing and able to perform study assessments and training during the full time period of 12 months Motivation to get the best possible results through training and realistic expectations about these as assessed in screening interview Exclusion Criteria: OCT shows significant retina edema and/or scar tissue within target region for implant Heavy clumped pigmentation at posterior pole or on the planned route of the implantation atrophy of optic nerve or ganglion cells degeneration Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment) Deep amblyopia reported earlier in life on eye to be implanted Systemic conditions that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular/pulmonary diseases, severe metabolic diseases) Acute and severe neurological and/or psychiatric diseases Hyperthyroidism or hypersensitivity to iodine Hypersensitivity to fluorescent dye 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 study within the past 30 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Leveziel, Prof

Organizational Affiliation

Centre Hospitalier Universitaire (CHU) de Poitiers, France

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Pierre-André Duval, Dr

Organizational Affiliation

Clinique Saint Jean, Montpellier, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique Saint Jean

City

Montpellier

State/Province

Hérault

ZIP/Postal Code

34093

Country

France

Facility Name

Centre Hospitalier Universitaire La Milétrie de Poitiers

City

Poitiers

State/Province

Vienne

ZIP/Postal Code

86021

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

If data are shared, this will only be done in a pseudonymized manner.

Citations:

PubMed Identifier

28878616

Citation

Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kuhlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schroder GS, Tode J, Troelenberg N, Zrenner E. Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations. Front Neurosci. 2017 Aug 23;11:445. doi: 10.3389/fnins.2017.00445. eCollection 2017.

Results Reference

background

PubMed Identifier

29110946

Citation

Edwards TL, Cottriall CL, Xue K, Simunovic MP, Ramsden JD, Zrenner E, MacLaren RE. Assessment of the Electronic Retinal Implant Alpha AMS in Restoring Vision to Blind Patients with End-Stage Retinitis Pigmentosa. Ophthalmology. 2018 Mar;125(3):432-443. doi: 10.1016/j.ophtha.2017.09.019. Epub 2017 Oct 27.

Results Reference

background

Links:

URL

http://www.retina-implant.de

Description

Retina Implant AG Sponsor homepage

Learn more about this trial

Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

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