Safety and Tolerability of a Prostaglandin Ocular Implant... | NCT03604328

Studies
Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma

NCT03604328

Sponsor

PolyActiva Pty Ltd

Status

Completed

Last Update Posted

Sep 16, 2020Actual

Enrollment

8Actual

Phase

Phase 1

Conditions

Open-angle Glaucoma

Interventions

PA5108

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2018Actual

Primary Completion Date

Jun 15, 2020Actual

Completion Date

Jun 15, 2020Actual

First Submitted Date

Jul 10, 2018

First Submission Date that Met QC Criteria

Jul 26, 2018

First Posted Date

Jul 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2020

Last Update Posted Date

Sep 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PA5108	Experimental	PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye)	Drug: PA5108

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PA5108	Drug	single ocular implant, administered on day 1	PA5108

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability as measured by the occurrence of adverse events		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Timeframe to complete implant biodegradation based on implant size and location		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nathan Kerr	The Royal Victorian Eye & Ear Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Eye Research Australia		East Melbourne	Victoria	3002	Australia
Melbourne Eye Specialists

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided