Pilot Study of a Suprachoroidal Retinal Prosthesis

NCT01603576 | Completed

• 2 other identifiers: BVA_0001090/2012
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Retinitis Pigmentosa; Choroideremia

Outcome Measures

Primary Outcomes (1)

• Safety

  Number of device-related serious adverse events

  18 months

Secondary Outcomes (1)

• Ability to perceive visual percepts during device stimulation

  18 months

Study Arms (1)

Suprachoroidal retinal prosthesis

EXPERIMENTAL

Device: Prototype wide view suprachoroidal retinal prosthesis

Interventions

Prototype wide view suprachoroidal retinal prosthesis DEVICE

Manufacturer = Bionics Institute, Australia

Suprachoroidal retinal prosthesis

Eligibility Criteria

• Age: 18 Years - 80 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
• 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)

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 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

Sponsors & Collaborators

• Center for Eye Research Australia: lead

Study Sites (2)

Nicta / Data61

Canberra, Australian Capital Territory, 2601, Australia

Location

Centre for Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Related Publications (5)

• 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.

  PMID: 28793152 DERIVED

• 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.

  PMID: 28660276 DERIVED

• 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.

  PMID: 27170910 DERIVED

• 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 DERIVED

• 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.

  PMID: 25205858 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

• Anthony Burkitt, PhD

  Bionic Vision Australia

  STUDY DIRECTOR

• Robyn Guymer, MBBS, PhD

  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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 22, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 16, 2016

Record last verified: 2016-11

Locations

AU (2)