Home › Trials › NCT06116916

Evaluating KHK4951 eye drops for diabetic macular edema

A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Diabetic Macular Edema

Phase 2 Interventional Kyowa Kirin Co., Ltd. · NCT06116916

This study is testing if KHK4951 eye drops can improve vision and reduce swelling in the eyes of people with diabetic macular edema compared to standard injections.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorKyowa Kirin Co., Ltd. Industry-sponsored
Drugs / interventionsranibizumab, bevacizumab
Locations87 sites (Mesa, Arizona and 86 other locations)
Trial IDNCT06116916 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of KHK4951 eye drops in patients suffering from diabetic macular edema (DME). Participants will receive either KHK4951 or Aflibercept injections, with their visual acuity and central subfield thickness monitored throughout the trial. The study is designed to determine how well KHK4951 can improve vision and reduce macular edema compared to standard treatments. It will involve patients aged 19 and older who meet specific eligibility criteria related to their eye condition and diabetes management.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with diabetic macular edema and specific visual acuity and central thickness measurements.

Not a fit: Patients with proliferative diabetic retinopathy or other significant ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients with diabetic macular edema.

How similar studies have performed: Other studies have shown promise in treating diabetic macular edema with similar approaches, but the specific efficacy of KHK4951 is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Voluntary written informed consent to participate in the study
* In Korea, participants must be 19 years or older to be enrolled
* BCVA ETDRS letter score of 78 letters to 35 letters as measured by the ETDRS visual acuity chart in the study eye at screening
* 500 μm ≥ CST ≥ 325 μm in the study eye at screening
* HbA1c ≤ 11% at screening

Exclusion Criteria:

* Any signs of proliferative diabetic retinopathy in the study eye
* History of rubeosis in the study eye
* Uncontrolled glaucoma in the study eye
* Aphakia or pseudophakia with AC-IOL in the study eye
* Active intraocular inflammation in the study eye
* Any current ocular condition for which visual acuity loss would not improve from resolution of macular edema in the study eye
* History of rhegmatogenous retinal detachment in the study eye
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
* History of the following therapies in the study eye

  * History of vitrectomy surgery, submacular surgery, or other surgical intervention for DME
  * Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 corticosteroids
  * Previous intraocular device implantation except PC-IOL
  * Laser (any type) to the macular area within 12 weeks prior to Day 1
  * Peripheral retinal photocoagulation therapy within 12 weeks prior to Day 1
  * Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars
  * Treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks prior to Day 1. Previously treated patients who received these medications more than 12 weeks prior to Day 1 can be enrolled, but the patients should be diagnosed with nAMD within 3 years prior to Day 1
  * Previous use of Ozurdex® or Iluvien® implant
* Any current or history of endophthalmitis in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Where this trial is running

Mesa, Arizona and 86 other locations

+37 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Macular Edema
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.