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

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 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
  • 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 IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars;
  • Previous treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks before being enrolled to the study. If a previously treated patient is enrolled, the patient should be diagnosed with AMD within 3 years before being enrolled to the study.

• 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

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180 participants in 3 patient groups

Arm A

Experimental group

Description:

KHK4951 High dose

Treatment:

Drug: Aflibercept Injection

Drug: KHK4951

Arm B

Experimental group

Description:

KHK4951 Middle dose

Treatment:

Drug: Aflibercept Injection

Drug: KHK4951

Arm C

Experimental group

Description:

KHK4951 Low dose

Treatment:

Drug: Aflibercept Injection

Drug: KHK4951