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

Running, not enrolling · Phase 2

Conditions studied: Neovascular Age-Related Macular Degeneration (nAMD)

In brief

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

Key facts

Study ID

NCT06116890

Run by

Kyowa Kirin Co., Ltd.

People needed

180

Starts

2024-01-31

Expected to finish

2026-09-30

Last updated by the study team

2025-10-30

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Adelaide Eye and Retina Centre — Adelaide, South Australia, Australia
• Centre for Eye Research Australia — East Melbourne, Victoria, Australia
• Aichi Medical University Hospital - Ophthalmology — Nagakute, Aichi-ken, Japan
• MIYAKE Eye Hospital — Nagoya, Aichi-ken, Japan
• Toho University Medical Center Sakura Hospital — Sakura, Chiba, Japan
• Matsuyama Red Cross Hospital — Matsuyama, Ehime, Japan
• Hayashi Eye Hospital - Ophthalmology — Fukuoka, Fukuoka, Japan
• Kurume University Hospital — Kurume, Fukuoka, Japan
• Minamitohoku Eye Clinic — Kōriyama, Fukushima, Japan
• Caress Sapporo Tokeidai Memorial Hospital — Sapporo, Hokkaido, Japan
• Kobe University Hospital - Ophthalmology — Kobe, Hyôgo, Japan
• Kozawa Eye Hospital and Diabetes Center — Mito, Ibaraki, Japan
• Kagawa University Hospital — Kita-gun, Kanagawa, Japan
• Shinshu University Hospital - Ophthalmology — Matsumoto, Nagano, Japan
• Nara Medical University Hospital - Ophthalmology — Kashihara, Nara, Japan
• University of the Ryukyus Hospital — Nakagami-gun, Okinawa, Japan
• Kansai Medical University Medical Center — Hirakata, Osaka, Japan
• Kindai University Hospital — Sayama, Osaka, Japan
• Jichi Medical University Hospital — Shimotsuke, Tochigi, Japan
• The University of Tokyo Hospital — Bunkyō, Tokyo, Japan
• Nihon University Hospital — Chiyoda City, Tokyo, Japan
• Tokyo Medical University Hachioji Medical Center — Hachiōji, Tokyo, Japan
• Tokyo Medical Center — Meguro City, Tokyo, Japan
• Keio University Hospital - Ophthalmology — Shinjuku, Tôkyô, Japan
• Sydney Eye Hospital — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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