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

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ClinicalTrials.gov Identifier: NCT03561922
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Retina Implant AG

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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : September 4, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2022


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Adverse Events [ Time Frame: 2 years ]
    Number, nature and severity of device-related and implantation-related adverse events

  4. Measure of implant-mediated visual function [ Time Frame: 2 years ]
    Computer test assessed with implant on versus off



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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561922


Contacts
Contact: Tessa Orgassa, Dr. +49 7121 36403 ext 273 tessa.orgassa@retina-implant.de
Contact: Katja Obri, MSc +49 7121 36403 ext 233 katja.obri@retina-implant.de

Locations
France
Clinique Saint Jean Recruiting
Montpellier, Hérault, France, 34093
Contact: Pierre-André Duval, Dr    +33 (0)688630807    montpellier@retine.tech   
Contact: Pascale Caradec, Assistante    +33 (0)430966767    montpellier@retine.tech   
Principal Investigator: Pierre-André Duval         
Sub-Investigator: Olivier Rebollo         
Centre Hospitalier Universitaire La Milétrie de Poitiers Recruiting
Poitiers, Vienne, France, 86021
Contact: Nicolas Leveziel, Prof    +33 (0)549444182    nicolas.leveziel@chu-poitiers.fr   
Principal Investigator: Nicolas Leveziel         
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

Additional Information:
Publications:
Responsible Party: Retina Implant AG
ClinicalTrials.gov Identifier: NCT03561922     History of Changes
Other Study ID Numbers: RI-FI-2017
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If data are shared, this will only be done in a pseudonymized manner.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Retina Implant AG:
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

Additional relevant MeSH terms:
Retinal Degeneration
Retinal Dystrophies
Retinal Diseases
Eye Diseases