Pilot Study of a Suprachoroidal Retinal Prosthesis

Retinitis Pigmentosa Clinical Trial

Official title:

Safety and Feasibility Study of a Prototype Suprachoroidal Retinal Prosthesis for Vision Restoration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603576
• Other study ID #: BVA_0001
• Secondary ID: 090/2012
• Status: Completed
• Phase: N/A
• First received: May 18, 2012
• Last updated: November 14, 2016
• Start date: May 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2016
• Source: Center for Eye Research Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroideremia
• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• Prototype wide view suprachoroidal retinal prosthesis
Manufacturer = Bionics Institute, Australia

Locations

Country	Name	City	State
Australia	Nicta / Data61	Canberra	Australian Capital Territory
Australia	Centre for Eye Research Australia	East Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Center for Eye Research Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Number of device-related serious adverse events	18 months	Yes
Secondary	Ability to perceive visual percepts during device stimulation	Number of participants able to perceive phosphenes when the device is stimulated	18 months	No