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

• Sponsor: PolyActiva Pty Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03604328
• Collaborator: (none)
• Enrollment: 8
• Locations: 2
• Arm: 1
• Actual Duration (Months): 22.7
• Patients Per Site: 4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma	Drug: PA5108	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• 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: Jul 24, 2018
• Actual Primary Completion Date: Jun 15, 2020
• Actual Study Completion Date: Jun 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability as measured by the occurrence of adverse events [4 weeks]

Secondary Outcome Measures

1. Timeframe to complete implant biodegradation based on implant size and location [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Eye Research Australia	East Melbourne	Victoria	Australia	3002
2	Melbourne Eye Specialists	Melbourne	Victoria	Australia	3000

Sponsors and Collaborators

• PolyActiva Pty Ltd

Investigators

• Principal Investigator: Nathan Kerr, The Royal Victorian Eye & Ear Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PolyActiva Pty Ltd
• ClinicalTrials.gov Identifier: NCT03604328
• Other Study ID Numbers: LATA-CS101
• First Posted: Jul 27, 2018
• Last Update Posted: Sep 16, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Glaucoma, Open-Angle

Study Results

No Results Posted as of Sep 16, 2020