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Pilot Study of a Suprachoroidal Retinal Prosthesis

Primary Purpose

Retinitis Pigmentosa, Choroideremia

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Prototype wide view suprachoroidal retinal prosthesis
Sponsored by
Center for Eye Research Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - 80 Years (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
  • Must be willing and able to comply with the testing and follow-up protocol demands (preferably residing within 1.5 hours of the investigational site)

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 subject 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
  • Subject 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 bionic eye device

Sites / Locations

  • Nicta / Data61
  • Centre for Eye Research Australia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suprachoroidal retinal prosthesis

Arm Description

Outcomes

Primary Outcome Measures

Safety
Number of device-related serious adverse events

Secondary Outcome Measures

Ability to perceive visual percepts during device stimulation
Number of participants able to perceive phosphenes when the device is stimulated

Full Information

First Posted
May 18, 2012
Last Updated
November 14, 2016
Sponsor
Center for Eye Research Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01603576
Brief Title
Pilot Study of a Suprachoroidal Retinal Prosthesis
Official Title
Safety and Feasibility Study of a Prototype Suprachoroidal Retinal Prosthesis for Vision Restoration
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Eye Research Australia

4. Oversight

5. Study Description

Brief Summary
This study will be an initial proof of concept study, to evaluate safety and efficacy of a prototype suprachoroidal retinal implant

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
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suprachoroidal retinal prosthesis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Prototype wide view suprachoroidal retinal prosthesis
Intervention Description
Manufacturer = Bionics Institute, Australia
Primary Outcome Measure Information:
Title
Safety
Description
Number of device-related serious adverse events
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Ability to perceive visual percepts during device stimulation
Description
Number of participants able to perceive phosphenes when the device is stimulated
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 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 Must be willing and able to comply with the testing and follow-up protocol demands (preferably residing within 1.5 hours of the investigational site) 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 subject 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 Subject 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 bionic eye device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Burkitt, PhD
Organizational Affiliation
Bionic Vision Australia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robyn Guymer, MBBS, PhD
Organizational Affiliation
Centre for Eye Research Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nicta / Data61
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2601
Country
Australia
Facility Name
Centre for Eye Research Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
28793152
Citation
Shivdasani MN, Sinclair NC, Gillespie LN, Petoe MA, Titchener SA, Fallon JB, Perera T, Pardinas-Diaz D, Barnes NM, Blamey PJ; Bionic Vision Australia Consortium. Identification of Characters and Localization of Images Using Direct Multiple-Electrode Stimulation With a Suprachoroidal Retinal Prosthesis. Invest Ophthalmol Vis Sci. 2017 Aug 1;58(10):3962-3974. doi: 10.1167/iovs.16-21311.
Results Reference
derived
PubMed Identifier
28660276
Citation
Petoe MA, McCarthy CD, Shivdasani MN, Sinclair NC, Scott AF, Ayton LN, Barnes NM, Guymer RH, Allen PJ, Blamey PJ; Bionic Vision Australia Consortium. Determining the Contribution of Retinotopic Discrimination to Localization Performance With a Suprachoroidal Retinal Prosthesis. Invest Ophthalmol Vis Sci. 2017 Jun 1;58(7):3231-3239. doi: 10.1167/iovs.16-21041.
Results Reference
derived
PubMed Identifier
27170910
Citation
Slater KD, Sinclair NC, Nelson TS, Blamey PJ, McDermott HJ; Bionic Vision Australia Consortium. neuroBi: A Highly Configurable Neurostimulator for a Retinal Prosthesis and Other Applications. IEEE J Transl Eng Health Med. 2015 Jul 13;3:3800111. doi: 10.1109/JTEHM.2015.2455507. eCollection 2015.
Results Reference
derived
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
derived
PubMed Identifier
25205858
Citation
Shivdasani MN, Sinclair NC, Dimitrov PN, Varsamidis M, Ayton LN, Luu CD, Perera T, McDermott HJ, Blamey PJ; Bionic Vision Australia Consortium. Factors affecting perceptual thresholds in a suprachoroidal retinal prosthesis. Invest Ophthalmol Vis Sci. 2014 Sep 9;55(10):6467-81. doi: 10.1167/iovs.14-14396.
Results Reference
derived

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Pilot Study of a Suprachoroidal Retinal Prosthesis

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