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Study of a Suprachoroidal Retinal Prosthesis

Primary Purpose

Retinitis Pigmentosa, Choroideremia

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
44Ch Bionic Eye Device
Sponsored by
Mobius Medical Pty Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 years or older
  • Either gender
  • A confirmed history of outer retinal degenerative disease such as retinitis pigmentosa or choroideremia
  • Remaining visual acuity of bare light perception or less in both eyes
  • Functional inner retina (ganglion cells and optic nerve), as shown by the ability to perceive light and/or a measurable corneal electrically evoked visual response
  • A history of at least 10 years of useful form vision in the worse seeing eye

Exclusion Criteria:

  • Optic nerve disease (history of glaucoma of More than 1 month, or history of any other optic neuropathy)
  • Diseases of the inner retina including, but not limited to, central retinal artery or vein occlusion (CRAO, CRVO), end stage diabetic retinopathy, retinal detachment, traumatic retinal damage, infectious retinal disease, inflammatory retinal disease.
  • Inability to visualise the retina due to corneal or other ocular media opacities (corneal degenerations, dense cataracts, trauma, lid malpositions)
  • Any ocular condition that predisposes the participant to rubbing their eyes
  • Cognitive deficiencies, including dementia or progressive neurological disease
  • Psychiatric disorders, including depression, as diagnosed by a qualified psychologist
  • Deafness or significant hearing loss
  • Inability to speak or understand English
  • Pregnancy
  • Presence of a cochlear implant
  • Participant enrolled in another investigational drug or device trial for the treatment of their ocular condition
  • Poor general health, which would exclude them from obtaining a general anaesthetic
  • Unrealistic expectations of the investigational device to provide functional vision
  • Poorly controlled diabetes
  • Epilepsy
  • Unsuitable level of regular nystagmus (which would prevent ocular images from being obtained)
  • Anyone with medical devices (implanted or carried) that could cause serious health problems if compromised by electro-magnetic interference

Sites / Locations

  • Centre for Eye Research Australia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suprachoroidal retinal prosthesis

Arm Description

Prototype wide view suprachoroidal retinal prosthesis

Outcomes

Primary Outcome Measures

Number and severity of device related serious adverse events (SAEs)
The safety of the surgical implantation assessed by the number and severity of serious adverse events (SAEs) compared to other retinal prosthesis.

Secondary Outcome Measures

Efficacy - visual response
The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.
Visual Function and Functional Vision
Visual function and Functional Vision will be scored from performance on a range of acuity, orientation and mobility, and activities of daily living tasks. Outcome measures include: Grating visual acuity: record the grating acuity level and average response time. Square localization: response error and response time is measured. Motion detection: response error and response time is measured. Table top task: locate and identify objects on a table. Accuracy rates and response times will be recorded. Doorway detection task: to find doorway target. Task time and accuracy of door touch will be recorded. Obstacle avoidance task: task time and number of collisions is recorded. Functional Low Vision Observer Rated Assessment (FLORA): this assessment tool Is used to evaluate participant functional vision and mobility.
Quality of life - IVI - very low vision validated questionnaire
Quality of life will be assessed via survey and self-report. The Functional Low Vision Observer Assessment (FLORA) is a questionnaire that will be used to measure participants changes in participant daily living experiences.

Full Information

First Posted
December 26, 2017
Last Updated
August 13, 2021
Sponsor
Mobius Medical Pty Ltd.
Collaborators
Bionic Vision Technologies, Centre for Eye Research Australia, Bionics Institute, University of Melbourne, Data 61 CSIRO, Australian National University
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1. Study Identification

Unique Protocol Identification Number
NCT03406416
Brief Title
Study of a Suprachoroidal Retinal Prosthesis
Official Title
Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mobius Medical Pty Ltd.
Collaborators
Bionic Vision Technologies, Centre for Eye Research Australia, Bionics Institute, University of Melbourne, Data 61 CSIRO, Australian National University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.
Detailed Description
Retinal visual prostheses are currently in early development as an intervention to improve functional vision in people who have become blind from retinal degenerative eye disease. This study follows on from an initial proof of concept study (n=3) between 2012 and 2014, and will test a second-generation retinal prosthesis device, which has the ability to be used outside of the laboratory environment (i.e. is fully implantable).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Choroideremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suprachoroidal retinal prosthesis
Arm Type
Experimental
Arm Description
Prototype wide view suprachoroidal retinal prosthesis
Intervention Type
Device
Intervention Name(s)
44Ch Bionic Eye Device
Intervention Description
Prototype wide view suprachoroidal retinal prosthesis
Primary Outcome Measure Information:
Title
Number and severity of device related serious adverse events (SAEs)
Description
The safety of the surgical implantation assessed by the number and severity of serious adverse events (SAEs) compared to other retinal prosthesis.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Efficacy - visual response
Description
The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.
Time Frame
2 years
Title
Visual Function and Functional Vision
Description
Visual function and Functional Vision will be scored from performance on a range of acuity, orientation and mobility, and activities of daily living tasks. Outcome measures include: Grating visual acuity: record the grating acuity level and average response time. Square localization: response error and response time is measured. Motion detection: response error and response time is measured. Table top task: locate and identify objects on a table. Accuracy rates and response times will be recorded. Doorway detection task: to find doorway target. Task time and accuracy of door touch will be recorded. Obstacle avoidance task: task time and number of collisions is recorded. Functional Low Vision Observer Rated Assessment (FLORA): this assessment tool Is used to evaluate participant functional vision and mobility.
Time Frame
2 years
Title
Quality of life - IVI - very low vision validated questionnaire
Description
Quality of life will be assessed via survey and self-report. The Functional Low Vision Observer Assessment (FLORA) is a questionnaire that will be used to measure participants changes in participant daily living experiences.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older Either gender A confirmed history of outer retinal degenerative disease such as retinitis pigmentosa or choroideremia Remaining visual acuity of bare light perception or less in both eyes Functional inner retina (ganglion cells and optic nerve), as shown by the ability to perceive light and/or a measurable corneal electrically evoked visual response A history of at least 10 years of useful form vision in the worse seeing eye Exclusion Criteria: Optic nerve disease (history of glaucoma of More than 1 month, or history of any other optic neuropathy) Diseases of the inner retina including, but not limited to, central retinal artery or vein occlusion (CRAO, CRVO), end stage diabetic retinopathy, retinal detachment, traumatic retinal damage, infectious retinal disease, inflammatory retinal disease. Inability to visualise the retina due to corneal or other ocular media opacities (corneal degenerations, dense cataracts, trauma, lid malpositions) Any ocular condition that predisposes the participant to rubbing their eyes Cognitive deficiencies, including dementia or progressive neurological disease Psychiatric disorders, including depression, as diagnosed by a qualified psychologist Deafness or significant hearing loss Inability to speak or understand English Pregnancy Presence of a cochlear implant Participant enrolled in another investigational drug or device trial for the treatment of their ocular condition Poor general health, which would exclude them from obtaining a general anaesthetic Unrealistic expectations of the investigational device to provide functional vision Poorly controlled diabetes Epilepsy Unsuitable level of regular nystagmus (which would prevent ocular images from being obtained) Anyone with medical devices (implanted or carried) that could cause serious health problems if compromised by electro-magnetic interference
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penelope Allen, FRACO, FRACS
Organizational Affiliation
Centre for Eye Research Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Eye Research Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25521292
Citation
Ayton LN, Blamey PJ, Guymer RH, Luu CD, Nayagam DA, Sinclair NC, Shivdasani MN, Yeoh J, McCombe MF, Briggs RJ, Opie NL, Villalobos J, Dimitrov PN, Varsamidis M, Petoe MA, McCarthy CD, Walker JG, Barnes N, Burkitt AN, Williams CE, Shepherd RK, Allen PJ; Bionic Vision Australia Research Consortium. First-in-human trial of a novel suprachoroidal retinal prosthesis. PLoS One. 2014 Dec 18;9(12):e115239. doi: 10.1371/journal.pone.0115239. eCollection 2014.
Results Reference
background
PubMed Identifier
36066322
Citation
Abbott CJ, Baglin EK, Kolic M, McGuinness MB, Titchener SA, Young KA, Yeoh J, Luu CD, Ayton LN, Petoe MA, Allen PJ. Interobserver Agreement of Electrode to Retina Distance Measurements in a Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis. Transl Vis Sci Technol. 2022 Sep 1;11(9):4. doi: 10.1167/tvst.11.9.4.
Results Reference
derived
PubMed Identifier
35696133
Citation
Titchener SA, Nayagam DAX, Kvansakul J, Kolic M, Baglin EK, Abbott CJ, McGuinness MB, Ayton LN, Luu CD, Greenstein S, Kentler WG, Shivdasani MN, Allen PJ, Petoe MA. A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: Long-Term Observation of the Electrode-Tissue Interface. Transl Vis Sci Technol. 2022 Jun 1;11(6):12. doi: 10.1167/tvst.11.6.12.
Results Reference
derived
PubMed Identifier
34581770
Citation
Petoe MA, Titchener SA, Kolic M, Kentler WG, Abbott CJ, Nayagam DAX, Baglin EK, Kvansakul J, Barnes N, Walker JG, Epp SB, Young KA, Ayton LN, Luu CD, Allen PJ; Bionics Institute and Centre for Eye Research Australia Retinal Prosthesis Consortium. A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: Interim Clinical Trial Results. Transl Vis Sci Technol. 2021 Aug 12;10(10):12. doi: 10.1167/tvst.10.10.12.
Results Reference
derived
PubMed Identifier
34383875
Citation
Karapanos L, Abbott CJ, Ayton LN, Kolic M, McGuinness MB, Baglin EK, Titchener SA, Kvansakul J, Johnson D, Kentler WG, Barnes N, Nayagam DAX, Allen PJ, Petoe MA. Functional Vision in the Real-World Environment With a Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis. Transl Vis Sci Technol. 2021 Aug 12;10(10):7. doi: 10.1167/tvst.10.10.7.
Results Reference
derived

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Study of a Suprachoroidal Retinal Prosthesis

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