OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

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

PHASE1ACTIVE_NOT_RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

  1. Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.
  2. Advanced or severe glaucoma
  3. Disqualifying central corneal thickness in either eye
  4. Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health
  5. Uncontrolled medical conditions
  6. Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye
  7. 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
  8. 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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06964061

Intervention or treatment

COMBINATION_PRODUCT: PA5436 Ocular Implant, 115mcg

Conditions

  • Open Angle Glaucoma (OAG)
  • Ocular Hypertension (OH)

  • Condition: Open Angle Glaucoma (OAG), Ocular Hypertension (OH)

  • COMBINATION_PRODUCT: PA5436 Ocular Implant, 115mcg

  • Doncaster, Victoria, Australia and more

  • Sponsor: PolyActiva Pty Ltd

Save

Share

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Cataract & Eye Surgery Centre

Select from list below to view details:

  • Cataract & Eye Surgery Centre

    Doncaster, Victoria, Australia

  • Melbourne Eye Specialists

    Melbourne, Victoria, Australia

Loading map...

Who is running the clinical trial?

PPL

PolyActiva Pty Ltd

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: PA5436 Ocular Implant, 115mcg
  • PA5436 Ocular Implant, 115mcg administered by the Investigator into the anterior chamber of the study eye through a clear corneal injection
Combination Product: PA5436 Ocular Implant, 115mcg

    What is the study measuring?

    Primary Outcome

    MeasureDescriptionTime Frame
    Efficacy: change in mean diurnal intraocular pressure in study eyeNot SpecifiedWeeks 2, 12, 26 and 52
    Incidence of ocular symptoms and ocular treatment-emergent adverse eventsOcular safety and tolerability (AEs)Day 1 through study completion at least until Week 52

    Secondary Outcome

    MeasureDescriptionTime Frame
    Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.Not SpecifiedWeeks 2-52
    Are you running this trial?If you're a clinic or sponsor, you can claim this study.
    Claim this trial

    References

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

    Other trials to consider

    Loading suggested trials...

    Top searched conditions

    Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular