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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 5, 2019

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.

Interventions

  • Device: RETINA IMPLANT Alpha AMS
    • Implantation of the subretinal RETINA IMPLANT Alpha AMS

Arms, Groups and Cohorts

  • Experimental: RETINA IMPLANT Alpha AMS
    • All participants receive the subretinal device RETINA IMPLANT Alpha AMS

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • Adverse Events
    • Time Frame: 2 years
    • Number, nature and severity of device-related and implantation-related adverse events
  • Measure of implant-mediated visual function
    • Time Frame: 2 years
    • Computer test assessed with implant on versus off

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 78 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Retina Implant AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicolas Leveziel, Prof, Study Chair, Centre Hospitalier Universitaire (CHU) de Poitiers, France
    • Pierre-André Duval, Dr, Principal Investigator, Clinique Saint Jean, Montpellier, France

References

Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kühlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schröder 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.

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.

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