RecruitingPhase 2

Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema

Australia28 participantsStarted 2025-05-01

Plain-language summary

This is a multi-center, open label study to assess the safety, tolerability, and efficacy of KIO-104 administered by IVT injection to the study eye of eligible participants with macular edema.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Be aged 18 to 85 years inclusive at the time of consent.
✓. Provide informed consent prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines.
✓. Be willing and able to follow all study instructions, attend all study visits, and complete all study assessments.
✓. Have a clinical diagnosis of ME in the study eye secondary to non-infectious uveitis, retinal vein occlusion, diabetic retinopathy or cataract surgery.
✓. If currently receiving systemic corticosteroid therapy or immunosuppressive therapy (or any combination thereof), be on a stable dose of therapy for at least 3 months prior to Screening and during the study.
✓. Have a Central Subfield Thickness (CST) of ≥ 350 µm.
✓. Have a Best Corrected Visual Acuity (BCVA) in the study eye of:
✓. ≤ 20/32 (Feet); logMAR ≥ 0.2

Exclusion criteria

✕. Have media opacities (cornea, anterior or posterior synechia, cataract, vitreous haze and others) of either eye that preclude investigation and documentation of the posterior pole and intravenous fluorescein angiography, or optical coherence tomography evaluation in the study eye.
✕. Receive local or systemic biologicals (i.e. tumour necrosis factor \[TNF\]-blockers, B-cell blockers, cytokines, cytokine-blockers, receptor antagonists) 90 days prior to Day 1 or planned during the study.
✕. Receive treatment with cyclophosphamide or chlorambucil during the study.
✕. Receive intravitreal injections (including but not limited to anti-vascular endothelial growth factors) 90 days prior to Day 1 or planned during the study.
✕. Receive a posterior subtenon's or orbital floor injection of steroids 90 days prior to Day 1 or planned during the study.
✕. Have any implantable corticosteroid-eluting device (Ozurdex, Iluvien, Retisert, triamcinolone intravitreal implant, fluocinolone intravitreal implant) in the study eye, with the following exceptions:
✕. If the device had been removed more than 90 days prior to Day 1 of the study.
✕. If Ozurdex® had been implanted at least 6 months before Day 1 of the study.

What they're measuring

Safety and Tolerability

Timeframe: 23months

Trial details

NCT IDNCT06825702

SponsorKiora Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Claudia Gregorio-King

+61 421 992 076 clinical@kiorapharma.com

View on ClinicalTrials.gov More Macular Edema trials