Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension

PolyActiva

Status and phase: Enrolling; Phase 1

Conditions: Open Angle Glaucoma (OAG); Ocular Hypertension (OH)

Treatments: Combination Product: PA5436 Ocular Implant, 115mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06964061

LATA-CS104

Details and patient eligibility

About

The goal of this clinical study is to learn how effective and safe is a single administration of PA5346 Ocular Implant for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension. It will also assess how long it takes for PA5346 Ocular Implant to dissolve in the eye.

Full description

This is an open-label study that will evaluate the efficacy, safety, tolerability and biodegradation of PA5346 Ocular Implant administered as a single dose at 115mcg in adults with open-angle glaucoma or ocular hypertension.

The study plans to recruit approximately 12 participants. Eligible participants will receive a single PA5346 Ocular Implant administered into the intracameral space of the study eye and followed for approximately 52 weeks at a minimum or until the implant is no longer visible in the study eye.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

PA5436 Ocular Implant, 115mcg

Experimental group

Description:

PA5436 Ocular Implant, 115mcg administered by the Investigator into the anterior chamber of the study eye through a clear corneal injection

Treatment:

Combination Product: PA5436 Ocular Implant, 115mcg