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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01603576




Registration number
NCT01603576
Ethics application status
Date submitted
18/05/2012
Date registered
22/05/2012
Date last updated
16/11/2016

Titles & IDs
Public title
Pilot Study of a Suprachoroidal Retinal Prosthesis
Scientific title
Safety and Feasibility Study of a Prototype Suprachoroidal Retinal Prosthesis for Vision Restoration
Secondary ID [1] 0 0
090/2012
Secondary ID [2] 0 0
BVA_0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinitis Pigmentosa 0 0
Choroideremia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Prototype wide view suprachoroidal retinal prosthesis

Experimental: Suprachoroidal retinal prosthesis -


Treatment: Devices: Prototype wide view suprachoroidal retinal prosthesis
Manufacturer = Bionics Institute, Australia
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Ability to perceive visual percepts during device stimulation
Timepoint [1] 0 0
18 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Recruitment hospital [1] 0 0
Nicta / Data61 - Canberra
Recruitment hospital [2] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment postcode(s) [1] 0 0
2601 - Canberra
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Center for Eye Research Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will be an initial proof of concept study, to evaluate safety and efficacy of a prototype suprachoroidal retinal implant
Trial website
https://clinicaltrials.gov/study/NCT01603576
Trial related presentations / publications
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Burkitt, PhD
Address 0 0
Bionic Vision Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01603576