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Evaluating KHK4951 eye drops for treating neovascular age-related macular degeneration

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 Neovascular Age-Related Macular Degeneration

PHASE2 · Kyowa Kirin Co., Ltd. · NCT06116890

This study is testing if KHK4951 eye drops can help improve vision in people with neovascular age-related macular degeneration compared to standard injections.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment180 (estimated)
Ages50 Years and up
SexAll
SponsorKyowa Kirin Co., Ltd. (industry)
Drugs / interventionsranibizumab, bevacizumab, radiation
Locations84 sites (Mesa, Arizona and 83 other locations)
Trial IDNCT06116890 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of KHK4951 eye drops in patients diagnosed with neovascular age-related macular degeneration (nAMD). Participants will receive either KHK4951 or Aflibercept injections, with their visual acuity and retinal condition monitored throughout the trial. The study will include patients with specific criteria related to their macular neovascularization and visual acuity levels. The goal is to determine if KHK4951 can effectively improve vision and manage the condition.

Who should consider this trial

Good fit: Ideal candidates are individuals with active subfoveal or juxtafoveal/extrafoveal macular neovascularization secondary to AMD and specific visual acuity scores.

Not a fit: Patients with significant retinal damage, uncontrolled glaucoma, or other ocular conditions that would not benefit from the resolution of macular edema may not receive any benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from nAMD, potentially improving their vision and quality of life.

How similar studies have performed: Other studies have shown promise in treating nAMD 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
* Active subfoveal MNV (any subtype) or juxtafoveal/extrafoveal MNV secondary to AMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) judged by the central reading center at screening
* BCVA ETDRS letter score of 78 letters to 35 letters in the study eye as measured by the ETDRS visual acuity chart at screening
* CST ≥ 450 μm at screening

Exclusion Criteria:

* Subretinal hemorrhage, fibrosis, or atrophy of \> 50% of the total lesion area and/or that involves the fovea 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 nAMD in the study eye that may confound assessment of the macula or affect central vision
* History of the following therapies in the study eye:

  * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  * Prior treatment PDT with Visudyne®, external-beam radiation therapy, transpupillary thermotherapy, or panretinal photocoagulation
  * Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1
  * Previous intraocular device implantation except PC-IOL
  * Previous laser (any type) to the macular area
  * 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
* 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 83 other locations

+34 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 →

Conditions: Neovascular Age-Related Macular Degeneration

Last reviewed 2026-05-15 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.