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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03604328




Registration number
NCT03604328
Ethics application status
Date submitted
10/07/2018
Date registered
27/07/2018
Date last updated
20/03/2019

Titles & IDs
Public title
Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma
Scientific title
An Open-label Phase I Study to Evaluate the Safety, Tolerability and Biodegradation Period of PolyActiva PA5108 Ocular Implant When Administered Intracamerally to the Anterior Chamber of the Eye
Secondary ID [1] 0 0
LATA-CS101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open-angle Glaucoma 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PA5108

Experimental: PA5108 - PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye)


Treatment: Drugs: PA5108
single ocular implant, administered on day 1

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability as measured by the occurrence of adverse events
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Timeframe to complete implant biodegradation based on implant size and location
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
- Grade 3 or 4 open angle glaucoma (Shaffer-Etienne scale)

- Visual acuity in non-study eye same or better than study eye

- Currently taking topical ocular hypotensive medication including a prostaglandin
analogue
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Aphakic eyes

- Only one eye

- History of, or current uveitis, Cystoid Macular Edema (CME) or cornea edema

- Intraocular surgery or cornea/refractive surgery in study eye in past 6 months or
anticipate need for eye surgery (including laser) in study eye during study period

- Current retinal detachment

- Uncontrolled infection in the eye

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
PolyActiva Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A single centre, open label, study to assess the safety, tolerability and biodegradation of
PA5108 ocular implant in adults who have Open Angle Glaucoma (Primary or Secondary).
Participants who are currently managing their Open Angle Glaucoma with combination drop
therapy 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
https://clinicaltrials.gov/show/NCT03604328
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nathan Kerr
Address 0 0
The Royal Victorian Eye & Ear Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Russell Tait
Address 0 0
Country 0 0
Phone 0 0
+61396570700
Fax 0 0
Email 0 0
russell.tait@polyactiva.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03604328