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Tests treatment safety and results for Macular Edema
Official title Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema
ClinicalTrials.gov ID: NCT06825702
What this study is testing
What is KIO-104?
KIO-104 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for macular edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Participants must meet all the following 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...
You likely can't join if
- Participants must not meet any of the following criteria:
- Have media opacities (cornea, anterior or posterior synechia, cataract, vitreous haze and others) of either eye that preclude investigation and...
- Receive local or systemic biologicals (i.e. tumour necrosis factor [TNF]-blockers, B-cell blockers, cytokines, cytokine-blockers, receptor...
- 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...
- Receive a posterior subtenon's or orbital floor injection of steroids 90 days prior to Day 1 or planned during the study.
See the full eligibility criteria
Who can join
- Participants must meet all the following 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 (6/9.5); logMAR ≥ 0.2; ≤ 75 ETDRS letters
- ≥ 20/800 (6/240); logMAR ≤ 1.6; ≥ 5 ETDRS letters
- Have media clarity and pupillary dilation sufficient for adequate visualization and assessment of the study eye.
- Be willing to avoid disallowed medications and treatments for the duration of the study.
- Agree to follow appropriate contraception requirements from screening until 3 months after the last dose of the study drug.
- Participants assigned female at birth who are of child-bearing potential (OCBP) must agree to a pregnancy test at Screening and prior to each dose of investigational medicinal product (IMP) and use an acceptable method...
- Participants assigned female at birth are not OCBP if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or are post-menopausal by at least 12 months. Post-menopausal status of amenorrheic...
- Participants assigned male at birth with a partner OCBP must be surgically sterile for at least 3 months prior to starting study drug, or ensure their partner uses contraception as outlined above, and must use a male...
- Participants who have practiced true abstinence for at least 1 year due to usual and preferred lifestyle choice are exempt from contraceptive requirements. If a participant who is abstinent becomes sexually active, they...
What rules you out
- Participants must not meet any of the following 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...
- 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.
- If Iluvien® or Retisert® had been implanted at least 3 years before Day 1 of the study.
- Use of topical steroids are permissible provided the participant is receiving a stable dose for at least 3 months prior to Screening and during the study.
- Have ocular surgery (including cataract extraction, laser surgery such as pan retinal photocoagulation, vitreoretinal or scleral buckling surgery) in the study eye, within 90 days prior to Day 1, or planned during the...
- Have a capsulotomy in the study eye, within 30 days prior to Day 1, and during the study.
- Have Intraocular pressure (IOP) ≥ 25 mmHg in the study eye (glaucoma patients maintained on no more than one topical medication with IOP \< 25 mmHg are allowed to participate).
- Have ocular hypotony (IOP \< 6 mmHg) in the study eye.
- Have aphakia or anterior chamber lens in the study eye.
- Have visible scleral thinning, scleral ectasia or keratoconus in the study eye.
- Have presence of any ocular malignancy in either eye.
- Have evidence of any other clinically significant ocular disease that might interfere with the study assessments.
- Have ocular or periocular (either eye) or systemic infection and/or a temperature greater than 38.0°C, or the use of systemic or topical ocular antibiotics within 14 days of Day 1.
- Have a psychiatric condition that, in the Investigator's opinion, precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years...
- Have any clinically significant abnormality at screening determined by medical and ophthalmic history, vital signs, clinical biochemistry, hematology, urinalysis, or a 12-lead electrocardiogram (ECG), as assessed by the...
- Have any other medical condition or significant co-morbidities, or any finding during screening, which in the view of the Investigator is likely to interfere with the study or put the participant at risk, confound study...
- Have participated in any other investigational drug or device clinical trial within 90 days prior to Day 1 or planning to participate in other investigational drug or device clinical trials during the study and within...
- Have any clinically significant clotting abnormality as assessed by the Investigator, which might interfere with the collection of blood samples required by the study.
- Have a known allergy or hypersensitivity to the study medication, any component of the delivery vehicle, any corticosteroids, any diagnostic agents used during the study (e.g., fluorescein, dilation drops), or any other...
- Be pregnant or breast-feeding, or plan to become pregnant during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Westmead, New South Wales, Australia
- Adelaide, South Australia, Australia
- Hobart, Tasmania, Australia
- East Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Westmead, New South Wales, Australia; Adelaide, South Australia, Australia; Hobart, Tasmania, Australia; East Melbourne, Victoria, Australia; Nedlands, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.