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

PolyActiva

Status and phase: Completed; Phase 1

Conditions: Open-angle Glaucoma

Treatments: Drug: PA5108

Study type: Interventional

Funder types: Industry

Identifiers

NCT03604328

LATA-CS101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

PA5108

Experimental group

Description:

PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye)

Treatment:

Drug: PA5108