The trial is taking place at:
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Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration

Kyowa Kirin logo

Kyowa Kirin

Status and phase

Enrolling
Phase 2

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Treatments

Drug: Aflibercept Injection
Drug: KHK4951

Study type

Interventional

Funder types

Industry

Identifiers

NCT06116890
4951-002

Details and patient eligibility

About

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

Enrollment

180 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

180 participants in 3 patient groups

Arm A
Experimental group
Description:
KHK4951 High dose
Treatment:
Drug: KHK4951
Drug: Aflibercept Injection
Arm B
Experimental group
Description:
KHK4951 Middle dose
Treatment:
Drug: KHK4951
Drug: Aflibercept Injection
Arm C
Experimental group
Description:
KHK4951 Low dose
Treatment:
Drug: KHK4951
Drug: Aflibercept Injection

Trial contacts and locations

82

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Central trial contact

Kyowa Kirin, Inc.

Data sourced from clinicaltrials.gov

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