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

April 17, 2019 updated by: Retina Implant AG
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hérault
      • Montpellier, Hérault, France, 34093
        • Clinique Saint Jean
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Centre Hospitalier Universitaire La Milétrie de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. OCT shows significant retina edema and/or scar tissue within target region for implant
  2. Heavy clumped pigmentation at posterior pole or on the planned route of the implantation
  3. atrophy of optic nerve or ganglion cells degeneration
  4. Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment)
  5. Deep amblyopia reported earlier in life on eye to be implanted
  6. Systemic conditions that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular/pulmonary diseases, severe metabolic diseases)
  7. Acute and severe neurological and/or psychiatric diseases
  8. Hyperthyroidism or hypersensitivity to iodine
  9. Hypersensitivity to fluorescent dye
  10. 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
  11. Participation in another interventional clinical study within the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional vision
Time Frame: baseline vs. 12 months after implantation
Instrumental Activities of Daily Living assessed at baseline (prior to implantation) versus one year after implantation
baseline vs. 12 months after implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vision Related Quality of Life - Questionnaire
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)
A validated patient reported outcome questionnaire, IVI-VLV, assessed at baseline versus one year after implantation
at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)
Visual Function - Questionnaire
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)
A validated patient reported outcome questionnaire, ULV-VFQ, assessed at baseline versus one year after implantation
at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)
Adverse Events
Time Frame: 2 years
Number, nature and severity of device-related and implantation-related adverse events
2 years
Measure of implant-mediated visual function
Time Frame: 2 years
Computer test assessed with implant on versus off
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2018

Primary Completion (Actual)

April 5, 2019

Study Completion (Actual)

April 5, 2019

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RI-FI-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinal Degeneration

Clinical Trials on RETINA IMPLANT Alpha AMS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe