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

Sponsor

Retina Implant AG (Industry)

Overall Status

Terminated

CT.gov ID

NCT03561922

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patient Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Degeneration Inherited Retinal Dystrophy Primarily Involving Sensory Retina	Device: RETINA IMPLANT Alpha AMS	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 4, 2018

Actual Primary Completion Date :

Apr 5, 2019

Actual Study Completion Date :

Apr 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RETINA IMPLANT Alpha AMS All participants receive the subretinal device RETINA IMPLANT Alpha AMS	Device: RETINA IMPLANT Alpha AMS Implantation of the subretinal RETINA IMPLANT Alpha AMS

Arm

Intervention/Treatment

Experimental: RETINA IMPLANT Alpha AMS

All participants receive the subretinal device RETINA IMPLANT Alpha AMS

Device: RETINA IMPLANT Alpha AMS

Implantation of the subretinal RETINA IMPLANT Alpha AMS

Outcome Measures

Primary Outcome Measures

Change in functional vision [baseline vs. 12 months after implantation]
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 [at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)]
A validated patient reported outcome questionnaire, IVI-VLV, assessed at baseline versus one year after implantation
Visual Function - Questionnaire [at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)]
A validated patient reported outcome questionnaire, ULV-VFQ, assessed at baseline versus one year after implantation
Adverse Events [2 years]
Number, nature and severity of device-related and implantation-related adverse events
Measure of implant-mediated visual function [2 years]
Computer test assessed with implant on versus off

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Saint Jean	Montpellier	Hérault	France	34093
2	Centre Hospitalier Universitaire La Milétrie de Poitiers	Poitiers	Vienne	France	86021

Sponsors and Collaborators

Retina Implant AG

Investigators

Study Chair: Nicolas Leveziel, Prof, Centre Hospitalier Universitaire (CHU) de Poitiers, France
Principal Investigator: Pierre-André Duval, Dr, Clinique Saint Jean, Montpellier, France