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

Phase 1

Completed

• Conditions: Open-angle Glaucoma
• Interventions: Drug: PA5108

• Registration Number: NCT03604328
• Lead Sponsor: PolyActiva Pty Ltd

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.

Study Timeline

• Study First Submitted: 2018-07-10
• Study Start: 2018-07-24
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Status Verified: 2020-03
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by the occurrence of adverse events	4 weeks

Secondary Outcome Measures

Name	Time	Method
Timeframe to complete implant biodegradation based on implant size and location	6 months

Trial Locations

Locations (2)

Melbourne Eye Specialists; 🇦🇺 Melbourne, Victoria, Australia

Centre for Eye Research Australia; 🇦🇺 East Melbourne, Victoria, Australia