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Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration

Recruiting
50 years of age
Both
Phase 2

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Overview

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.

Eligibility

Inclusion Criteria:

  • Voluntary written informed consent to participate in the study
  • Active subfoveal MNV (any subtype) or juxtafoveal MNV secondary to AMD with leakage affecting the fovea in the study eye at screening
  • BCVA ETDRS letter score of 73 letters to 35 letters in the study eye as measured by the ETDRS visual acuity chart at screening
  • CST ≥ 350 μm and ≤ 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
    • Previous use of periocular or intraocular (sub-Tenon or IVT) corticosteroids
    • Previous intraocular device implantation except PC-IOL
    • Previous laser (any type) to the macular area
    • Previous treatment with any IVT anti-VEGF drugs
  • 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

Study details

Neovascular Age-Related Macular Degeneration (nAMD)

NCT06116890

Kyowa Kirin, Inc.

9 June 2024

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