Status:
RECRUITING
Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
PolyActiva Pty Ltd
Collaborating Sponsors:
IUVO S.r.l.
Conditions:
Glaucoma, Open-Angle
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ocu...
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,...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
May 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06964191
Start Date
May 31 2025
End Date
November 15 2026
Last Update
June 13 2025
Active Locations (1)
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1
Eye Research Foundation
Newport Beach, California, United States, 92663