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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03604328
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : November 19, 2018
Information provided by (Responsible Party):
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). 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.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Drug: PA5108 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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

Primary Outcome Measures :
  1. Safety and tolerability as measured by the occurrence of adverse events [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Timeframe to complete implant biodegradation based on implant size and location [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03604328

Contact: Russell Tait +61396570700

Australia, Victoria
Centre for Eye Research Australia Recruiting
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
PolyActiva Pty Ltd
Principal Investigator: Nathan Kerr The Royal Victorian Eye & Ear Hospital

Responsible Party: PolyActiva Pty Ltd Identifier: NCT03604328     History of Changes
Other Study ID Numbers: LATA-CS101
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases