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

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

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).

Study Overview

• Status: Completed
• Conditions: Open-angle Glaucoma
• Intervention / Treatment: Drug: PA5108

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Centre For Eye Research Australia
    • Melbourne, Victoria, Australia, 3000
      • Melbourne Eye Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PA5108; PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye)	Drug: PA5108; single ocular implant, administered on day 1

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PolyActiva Pty Ltd
• Investigators: Principal Investigator: Nathan Kerr, The Royal Victorian Eye & Ear Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: LATA-CS101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No