NCT03604328

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

September 16, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

July 10, 2018

Last Update Submit

September 14, 2020

Conditions

Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability as measured by the occurrence of adverse events

    4 weeks

Secondary Outcomes (1)

  • Timeframe to complete implant biodegradation based on implant size and location

    6 months

Study Arms (1)

PA5108

EXPERIMENTAL

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

Drug: PA5108

Interventions

PA5108DRUG

single ocular implant, administered on day 1

PA5108

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Melbourne Eye Specialists

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Nathan Kerr

    The Royal Victorian Eye & Ear Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

July 27, 2018

Study Start

July 24, 2018

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

September 16, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)