NCT03561922

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

May 17, 2018

Last Update Submit

April 17, 2019

Conditions

Retinal DegenerationInherited Retinal Dystrophy Primarily Involving Sensory Retina

Keywords

Retinal DegenerationArtificial VisionRetinal ProsthesisSubretinal ImplantInherited Retinal DystrophyVision RestorationBionic EyeBionic VisionRetinitis PigmentosaArtificial RetinaRetina ImplantCone-Rod DystrophyChoroideremiaRetinopathia Pigmentosa

Outcome Measures

Primary Outcomes (1)

  • Change in functional vision

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

    baseline vs. 12 months after implantation

Secondary Outcomes (4)

  • 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)

  • 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)

  • Adverse Events

    2 years

  • Measure of implant-mediated visual function

    2 years

Study Arms (1)

RETINA IMPLANT Alpha AMS

EXPERIMENTAL

All participants receive the subretinal device RETINA IMPLANT Alpha AMS

Device: RETINA IMPLANT Alpha AMS

Interventions

RETINA IMPLANT Alpha AMSDEVICE

Implantation of the subretinal RETINA IMPLANT Alpha AMS

RETINA IMPLANT Alpha AMS

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Saint Jean

Montpellier, Hérault, 34093, France

Location

Centre Hospitalier Universitaire La Milétrie de Poitiers

Poitiers, Vienne, 86021, France

Location

Related Publications (2)

  • 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.

    PMID: 28878616BACKGROUND

  • 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.

    PMID: 29110946BACKGROUND

Related Links

MeSH Terms

Conditions

Retinal DegenerationRetinitis PigmentosaCone-Rod DystrophiesChoroideremia

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DiseasesRetinal DystrophiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChoroid DiseasesUveal DiseasesGenetic Diseases, X-Linked

Study Officials

  • Nicolas Leveziel, Prof

    Centre Hospitalier Universitaire (CHU) de Poitiers, France

    STUDY CHAIR

  • Pierre-André Duval, Dr

    Clinique Saint Jean, Montpellier, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

June 19, 2018

Study Start

September 4, 2018

Primary Completion

April 5, 2019

Study Completion

April 5, 2019

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

FR(2)