Clinical trial NCT03406416: Study of a Suprachoroidal Retinal Prosthesis
Official title: Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Choroideremia
Lead sponsor: Mobius Medical Pty Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Bionic Vision Technologies
name: Center for Eye Research Australia
name: The Bionics Institute of Australia
name: University of Melbourne
name: Data 61 CSIRO
name: Australian National University
First posted: 2018-01-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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).

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

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 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
* 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

Primary outcomes:
measure: Number and severity of device related serious adverse events (SAEs)
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy - visual response
timeFrame: 2 years
measure: Visual Function and Functional Vision
timeFrame: 2 years
measure: Quality of life - IVI - very low vision validated questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
Study officials:
affiliation: Center for Eye Research Australia
name: Penelope Allen, FRACO, FRACS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.