Study of a Suprachoroidal Retinal Prosthesis

NCT03406416 | Completed DMC

• 1 other identifier: BVT_001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinitis Pigmentosa; Choroideremia

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (3)

• Efficacy - visual response

  2 years

• Visual Function and Functional Vision

  2 years

• Quality of life - IVI - very low vision validated questionnaire

  2 years

Study Arms (1)

Suprachoroidal retinal prosthesis

EXPERIMENTAL

Prototype wide view suprachoroidal retinal prosthesis

Device: 44Ch Bionic Eye Device

Interventions

44Ch Bionic Eye Device DEVICE

Prototype wide view suprachoroidal retinal prosthesis

Suprachoroidal retinal prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mobius Medical Pty Ltd.: lead
• Bionic Vision Technologies: collaborator
• Center for Eye Research Australia: collaborator
• The Bionics Institute of Australia: collaborator
• University of Melbourne: collaborator
• Data 61 CSIRO: collaborator
• Australian National University: collaborator

Study Sites (1)

Centre for Eye Research Australia

Melbourne, Victoria, 3002, Australia

Location

Related Publications (5)

• 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.

  PMID: 25521292 BACKGROUND

• 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.

  PMID: 36066322 DERIVED

• 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.

  PMID: 35696133 DERIVED

• 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.

  PMID: 34581770 DERIVED

• 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.

  PMID: 34383875 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa; Choroideremia

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Choroid Diseases; Uveal Diseases; Genetic Diseases, X-Linked

Study Officials

• Penelope Allen, FRACO, FRACS

  Center for Eye Research Australia

  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: December 26, 2017
• First Posted: January 23, 2018
• Study Start: February 13, 2018
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)