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

NCT ID: NCT03604328

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-24

Study Completion Date

2020-06-15

Brief Summary

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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

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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.

Conditions

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Open-angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PA5108

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

Group Type EXPERIMENTAL

PA5108

Intervention Type DRUG

single ocular implant, administered on day 1

Interventions

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PA5108

single ocular implant, administered on day 1

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PolyActiva Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan Kerr

Role: PRINCIPAL_INVESTIGATOR

The Royal Victorian Eye & Ear Hospital

Locations

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Centre for Eye Research Australia

East Melbourne, Victoria, Australia

Site Status

Melbourne Eye Specialists

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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LATA-CS101

Identifier Type: -

Identifier Source: org_study_id

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