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Retinitis PigmentosaNCT03406416

Study of a Suprachoroidal Retinal Prosthesis

A study testing 44Ch Bionic Eye Device in people with Retinitis Pigmentosa and Choroideremia, run by Mobius Medical Pty Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinitis Pigmentosa, Choroideremia
What is being tested?
44Ch Bionic Eye Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteAustralia
Study dates
13 Feb 2018to 18 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Centre for Eye Research Australia

    Melbourne, Victoria, 3002

Other trials in Australia

About this study

Official title: Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study

This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.

Read the 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).

Being tested
44Ch Bionic Eye Device
Medical subject headings
Retinitis Pigmentosa, Choroideremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 44Ch Bionic Eye DeviceDevice

    Prototype wide view suprachoroidal retinal prosthesis

Study groups in NCT03406416
Study groupRoleWhat they receive
Suprachoroidal retinal prosthesisExperimentalPrototype wide view suprachoroidal retinal prosthesis
Receives: Device: 44Ch Bionic Eye Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (3)

  1. Efficacy - visual response

    The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.

    Measured: 2 years

  2. 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:

    1. Grating visual acuity: record the grating acuity level and average response time.
    2. Square localization: response error and response time is measured.
    3. Motion detection: response error and response time is measured.
    4. Table top task: locate and identify objects on a table. Accuracy rates and response times will be recorded.
    5. Doorway detection task: to find doorway target. Task time and accuracy of door touch will be recorded.
    6. Obstacle avoidance task: task time and number of collisions is recorded.
    7. Functional Low Vision Observer Rated Assessment (FLORA): this assessment tool Is used to evaluate participant functional vision and mobility.

    Measured: 2 years

  3. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start13 Feb 2018
  3. Primary completion18 Dec 2020
  4. Study completion18 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406416
Sponsor's protocol ID
BVT_001
Status last verified
Aug 2021
First submitted
26 Dec 2017
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25521292

  • 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.

    PubMed 36066322

  • 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.

    PubMed 35696133

  • 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.

    PubMed 34581770

  • 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.

    PubMed 34383875

Questions about this trial

What is this clinical trial studying?

A study testing 44Ch Bionic Eye Device in people with Retinitis Pigmentosa and Choroideremia, run by Mobius Medical Pty Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and severity of device related serious adverse events (SAEs) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03406416, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021; AzTrials last refreshed its copy on 28 Oct 2026.

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