Back to resultsSafety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma
Primary Purpose
Open-angle Glaucoma
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
PA5108
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma
Eligibility Criteria
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
Sites / Locations
- Centre for Eye Research Australia
- Melbourne Eye Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PA5108
Arm Description
PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye)
Outcomes
Primary Outcome Measures
Safety and tolerability as measured by the occurrence of adverse events
Secondary Outcome Measures
Timeframe to complete implant biodegradation based on implant size and location
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03604328
Brief Title
Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PolyActiva Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PA5108
Arm Type
Experimental
Arm Description
PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye)
Intervention Type
Drug
Intervention Name(s)
PA5108
Intervention Description
single ocular implant, administered on day 1
Primary Outcome Measure Information:
Title
Safety and tolerability as measured by the occurrence of adverse events
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Timeframe to complete implant biodegradation based on implant size and location
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Kerr
Organizational Affiliation
The Royal Victorian Eye & Ear Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Eye Research Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Melbourne Eye Specialists
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma
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