Phase I study of a Prostaglandin Ocular Implant for treatment of Open Angle Glaucoma

An open-label phase I study to evaluate the safety and tolerability of PolyActiva PA5108 ocular implant when administered intracamerally to the anterior chamber of the eye of participants with ocular hypertension..

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001026213

Enrollment

Registered

2018-06-19

Start date

2018-07-24

Completion date

2019-07-15

Last updated

2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A single centre, open label, sequential dose study to assess the safety and tolerability of two strengths of PA5108 ocular implant in adult who have Open Angle Glaucoma. Participants who are currently administering combination drop therapy for Open Angle Glaucoma 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.

Interventions

Sentinel Participant 1 - PA5108 (16ug) - administered via intracameral injection, single injection to one eye Sentinel Participant 2 - PA5108 (32ug) - administered via intracameral injection, single injection to one eye Participants 3 to 7 - PA5108 (60ug) - administered via intracameral injection, single injection to one eye Sentinel participant 2 will not be treated until after the 4 week safety assessment of Sentinel participant 1. Participants 3 to 7 will not be recruited until after the 4 week safety assessment of Sentinel participant 2. All administrations of the ocular implant will be undertaken by a qualified and trained ophthalmologist. All participants will continue to apply standard eye drop therapy to the non-treated eye to maintain intraocular pressure,

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Open Angle Glaucoma classified as grade 3 or 4 on the modified Shaffer-Etienne Scale A pseudophakic intent to treat eye At least one eye with irreversible sight of Snellen 6/60 or worse Currently administering combination eye drop therapy for open angle glaucoma

Exclusion criteria

Intraocular surgery or cornea/refractive surgery within past 6 months Participants with current uveitis, cystoid macular oedema, cornea oedema or retinal detachment Current Aphakic eyes Significant corneal guttatae Only one eye Uncontrolled infection of the eye

Outcome results