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OpenTrials
Completed

NCT Number: NCT03604328

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

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).

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Eye Research Australia, East Melbourne, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PA5108

Drug

single ocular implant, administered on day 1

Primary outcomes

  1. Safety and tolerability as measured by the occurrence of adverse events

    Time frame: 4 weeks

Secondary outcomes

  1. Timeframe to complete implant biodegradation based on implant size and location

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

PolyActiva Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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