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Trial registered on ANZCTR


Registration number
ACTRN12618001026213
Ethics application status
Approved
Date submitted
19/04/2018
Date registered
19/06/2018
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase I study of a Prostaglandin Ocular Implant for treatment of Primary Open Angle Glaucoma (POAG)
Scientific title
An open-label phase I study to evaluate the safety and tolerability of PolyActiva PA5108 ocular implant when administered intracamerally to the anterior chamber of the eye of participants with ocular hypertension..
Secondary ID [1] 294603 0
PolyActiva Pty Ltd - LATA-CS101 - Protocol Version 1.3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Open Angle Glaucoma (POAG) 307425 0
Condition category
Condition code
Eye 306517 306517 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sentinel Participant 1 - PA5108 (16ug) - administered via intracameral injection, single injection to one eye
Sentinel Participant 2 - PA5108 (32ug) - administered via intracameral injection, single injection to one eye
Participants 3 to 7 - PA5108 (60ug) - administered via intracameral injection, single injection to one eye
Sentinel participant 2 will not be treated until after the 4 week safety assessment of Sentinel participant 1. Participants 3 to 7 will not be recruited until after the 4 week safety assessment of Sentinel participant 2.

All administrations of the ocular implant will be undertaken by a qualified and trained ophthalmologist.

All participants will continue to apply standard eye drop therapy to the non-treated eye to maintain intraocular pressure,
Intervention code [1] 300906 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305528 0
To assess the safety and tolerability of PA5108 ocular implant in adults with Primary Open Angle Glaucoma (POAG). Assessments are undertaken by a qualified ophthalmologist and include standard ophthalmic assessments for visual acuity, intraocular pressure, slit-lamp biomicroscopy and gonioscopy.
Timepoint [1] 305528 0
Patients are assessed until the ocular implant has completely biodegraded. It is anticipated that the implant will completely degrade no sooner than 20 weeks and no later than 12 months after the date of administration.
Secondary outcome [1] 345807 0
Assess by examination with slit-lamp biomicroscopy and gonioscopy for the presence of the Pa5108 ocular implant to determine the period required for complete biodegradation.
Timepoint [1] 345807 0
Assessed at 4 weeks, 3, 4.5, 6, 9 and 12 months until the implant has completely degraded

Eligibility
Key inclusion criteria
Open Angle Glaucoma classified as grade 3 or 4 on the modified Shaffer-Etienne Scale
A pseudophakic intent to treat eye
At least one eye with irreversible sight of Snellen 6/60 or worse
Currently administering combination eye drop therapy for open angle glaucoma
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intraocular surgery or cornea/refractive surgery within past 6 months
Participants with current uveitis, cystoid macular oedema, cornea oedema or retinal detachment
Current Aphakic eyes
Significant corneal guttatae
Only one eye
Uncontrolled infection of the eye

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
All safety assessments will be summarised using descriptive statistics and presented by timepoint.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10685 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 22406 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 299222 0
Commercial sector/Industry
Name [1] 299222 0
PolyActiva Pty Ltd
Address [1] 299222 0
Level 9, 31 Queen St
Melbourne Victoria 3000
Country [1] 299222 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
PolyActiva Pty Ltd
Address
Level 9, 31 Queen St
Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 298488 0
None
Name [1] 298488 0
Address [1] 298488 0
Country [1] 298488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300144 0
The Royal Victorian Eye & Ear Hospital Human Research & Ethics Committee [EC00244]
Ethics committee address [1] 300144 0
32 Gisborne St
East Melbourne
Victoria 3002
Ethics committee country [1] 300144 0
Australia
Date submitted for ethics approval [1] 300144 0
Approval date [1] 300144 0
26/10/2017
Ethics approval number [1] 300144 0
17/1341H

Summary
Brief summary
A single centre, open label, sequential dose study to assess the safety and tolerability of two strengths of PA5108 ocular implant in adult who have Primary Open Angle Glaucoma (POAG). Participants who are currently administering combination drop therapy for POAG will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82694 0
Dr Nathan Kerr
Address 82694 0
Centre for Eye Research Australia
The Royal Victorian Eye and Ear Hospital
32 Gisborne St
East Melbourne 3002 Victoria
Country 82694 0
Australia
Phone 82694 0
+61 3 9929 8666
Fax 82694 0
Email 82694 0
n.kerr@unimelb.edu.au
Contact person for public queries
Name 82695 0
Dr Nathan Kerr
Address 82695 0
Centre for Eye Research Australia
The Royal Victorian Eye and Ear Hospital
32 Gisborne St
East Melbourne 3002 Victoria
Country 82695 0
Australia
Phone 82695 0
+61 9929 8666
Fax 82695 0
Email 82695 0
n.kerr@unimelb.edu.au
Contact person for scientific queries
Name 82696 0
Dr Russell Tait
Address 82696 0
PolyActiva Pty Ltd
Level 9, 31 Queen St
Melbourne 3000 Victoria
Country 82696 0
Australia
Phone 82696 0
+61 3 9657 0700
Fax 82696 0
Email 82696 0
russell.tait@polyactiva.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Subject to internal decision making on how we wish to report the trial results.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable