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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Phase 2, Open-label, Multiple Dose Study of the Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema (KLARITY-1)

Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema (NCT06825702) is a Phase 2 interventional studying Macular Edema, sponsored by Kiora Pharmaceuticals, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Macular Edema and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 28 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Participants must meet all the following criteria: 1. Be aged 18 to 85 years inclusive at the time of consent. 2. Provide willing to sign a consent form prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines. 3. Be willing and able to follow all study instructions, attend all study visits, and complete all study assessments. 4. Have a clinical diagnosis of ME in the study eye secondary to non-infectious uveitis, retinal vein occlusion, diabetic retinopathy or cataract surgery. 5. 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. 6. Have a Central Subfield Thickness (CST) of ≥ 350 µm. 7. Have a Best Corrected Visual Acuity (BCVA) in the study eye of: 1. ≤ 20/32 (Feet); logMAR ≥ 0.2 2. ≥ 20/800 (Feet); log MAR ≤ 1.6 8. Have media clarity and pupillary dilation sufficient for adequate visualization and assessment of the study eye. 9. Be willing to avoid disallowed medications and treatments for the duration of the study. 10. Agree to follow appropriate contraception requirements from screening until 3 months after the last dose of the study drug. 1. 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 of birth control including oral, transdermal, injectable, or implantable hormonal contraception, intrauterine device, abstinence from intercourse with partner assigned male at birth, or surgical sterilisation of partner assigned male at birth. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Participants must meet all the following criteria: 1. Be aged 18 to 85 years inclusive at the time of consent. 2. Provide informed consent prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines. 3. Be willing and able to follow all study instructions, attend all study visits, and complete all study assessments. 4. Have a clinical diagnosis of ME in the study eye secondary to non-infectious uveitis, retinal vein occlusion, diabetic retinopathy or cataract surgery. 5. 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. 6. Have a Central Subfield Thickness (CST) of ≥ 350 µm. 7. Have a Best Corrected Visual Acuity (BCVA) in the study eye of: 1. ≤ 20/32 (Feet); logMAR ≥ 0.2 2. ≥ 20/800 (Feet); log MAR ≤ 1.6 8. Have media clarity and pupillary dilation sufficient for adequate visualization and assessment of the study eye. 9. Be willing to avoid disallowed medications and treatments for the duration of the study. 10. Agree to follow appropriate contraception requirements from screening until 3 months after the last dose of the study drug. 1. 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 of birth control including oral, transdermal, injectable, or implantable hormonal contraception, intrauterine device, abstinence from intercourse with partner assigned male at birth, or surgical sterilisation of partner assigned male at birth. 2. 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 female participants should be confirmed at Screening through testing of follicle-stimulating hormone (FSH) as per analysing laboratory threshold. 3. 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 condom. Participants assigned male at birth must not donate sperm from Screening until 3 months after the last dose of IMP. 4. 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 must agree to use appropriate contraception as described above. Exclusion Criteria: Participants must not meet any of the following criteria: 1. 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. 2. 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. 3. Receive treatment with cyclophosphamide or chlorambucil during the study. 4. Receive intravitreal injections (including but not limited to anti-vascular endothelial growth factors) 90 days prior to Day 1 or planned during the study. 5. Receive a posterior subtenon's or orbital floor injection of steroids 90 days prior to Day 1 or planned during the study. 6. Have any implantable corticosteroid-eluting device (Ozurdex, Iluvien, Retisert, triamcinolone intravitreal implant, fluocinolone intravitreal implant) in the study eye, with the following exceptions: 1. If the device had been removed more than 90 days prior to Day 1 of the study. 2. If Ozurdex® had been implanted at least 6 months before Day 1 of the study. 3. If Iluvien® or Retisert® had been implanted at least 3 years before Day 1 of the study. 4. 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. 7. Have ocular surgery (including cataract extraction, vitreoretinal or scleral buckling surgery) in the study eye, within 90 days prior to Day 1, or planned during the study. 8. Have a capsulotomy in the study eye, within 30 days prior to Day 1, and during the study. 9. 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). 10. Have ocular hypotony (IOP \< 6 mmHg). 11. Have aphakia or anterior chamber lens in the study eye. 12. Have visible scleral thinning, scleral ectasia or keratoconus in the study eye. 13. Have presence of any ocular malignancy in either eye. 14. Have evidence of any other clinically significant ocular disease that might interfere with the study assessments. 15. 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. 16. 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 prior to screening, a history of suicide plan. 17. 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 investigator, which might interfere with the study assessments or the ability of the participant to complete the study. 18. 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 data, or interfere significantly with study participation. 19. 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 90 days following Day 1. This includes both ocular and non-ocular clinical trials. 20. Receive any anticoagulant or thrombocyte aggregation inhibiting agent (marcumar, warfarin, heparin, enoxaparin, apixaban, rivaroxaban, pentosanpolysulfate, dabigatran, aspirin and others) within 14 days prior to Day 1 or planned during the study. 21. 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 standard of care medications likely to be used during the study (e.g., antibiotic drops, povidone, rescue medications). 22. Be pregnant or breast-feeding, or plan to become pregnant during the study.

Treatments Being Tested

DRUG

KIO-104

KIO-104 is an ophthalmic formulation for IVT injection of the active pharmaceutical ingredient (API) KIO-100, a novel, non-steroidal, small molecule inhibitor of dihydroorotate dehydrogenase (DHODH).

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sydney Eye Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Centre for Eye Research Australia
East Melbourne, Victoria, Australia
Lions Eye Institute Limited
Nedlands, Western Australia, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06825702), the sponsor (Kiora Pharmaceuticals, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06825702 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06825702?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06825702?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06825702. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06825702. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.