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NCT03604328 Clinical Trial

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

Open-angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03604328
Other study ID # LATA-CS101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 24, 2018
Est. completion date June 15, 2020

Study information
Verified date March 2020
Source PolyActiva Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• PA5108
single ocular implant, administered on day 1

Locations
Country Name City State
Australia Centre for Eye Research Australia East Melbourne Victoria
Australia Melbourne Eye Specialists Melbourne Victoria

Sponsors (1)
Lead Sponsor Collaborator
PolyActiva Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability as measured by the occurrence of adverse events 4 weeks
Secondary Timeframe to complete implant biodegradation based on implant size and location 6 months
See also
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