Clinical trial NCT06964191: Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension
Official title: A Phase 2 Randomized, Multi-center, Parallel, Active-controlled Clinical Study to Evaluate the Safety and Efficacy of Intracameral PA5108 Ocular Implants in Patients With Primary Open-angle Glaucoma, or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: PolyActiva Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: IUVO S.r.l.
First posted: 2025-05-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.

Detailed description: This is a randomised, parallel, masked, active-controlled study that will evaluate the efficacy and safety of a low dose and a high dose of PA5108 Ocular Implant with single redosing during the study, in adults with open-angle glaucoma or ocular hypertension.

The study will also collect information on the implant administration procedure and overall experience from study participants.

The study plans to recruit approximately 75 participants.

Eligible participants will be randomly selected to receive one of the following treatments:

* PA5108 Ocular Implant - low dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
* PA5108 Ocular Implant - high dose in the study eye, and Latanoprost 0.005% eye drops in the other eye
* Latanoprost 0.005% eye drops in both eyes (control treatment group) If allocated to receive either of the ocular implants, a second implant of the same dose will be administered at 26 weeks and participants will be followed for safety and intraocular pressure control until week 58 or until the implant is no longer visible in the study eye.

Eligibility criteria: Key Inclusion Criteria:

* Ability to provide informed consent and follow study instructions
* 18 years of age or older
* Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
* Qualifying IOPs across 2 visits following washout of IOP-lowering medication, if applicable
* Qualifying best-corrected visual acuity BCVA using Early Treatment Diabetic Retinopathy Study (ETDRS) chart in study eye
* Qualifying corneal endothelial cell density (CEDC) in the study eye

Key Exclusion Criteria:

* Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.
* Advanced or severe glaucoma
* Disqualifying central corneal thickness in either eye
* Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
* Uncontrolled medical conditions
* Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye
* Have received intravitreal injections in the study eye within the last 3 months of the Screening Visit and anticipated need for an intravitreal injection during the course of the study
* Unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days

Primary outcomes:
measure: Efficacy: change in mean diurnal intraocular pressure in study eye
timeFrame: From Baseline to 12 weeks
measure: Incidence of ocular symptoms and ocular treatment-emergent adverse events.
timeFrame: Day 1 to study completion until at least Week 58
measure: Clinically significant change on slit-lamp exam
timeFrame: Day 1 to study completion until at least Week 58
measure: Clinically significant change in corneal endothelial cells
timeFrame: Day 1 to study completion until at least Week 58
Secondary outcomes:
measure: Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.
timeFrame: Weeks 2-52
Other outcomes:
measure: Exploratory: Gather data on implant administration procedure and overall experience from study participants.
timeFrame: At 24 and 58 weeks
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
References: