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

Last updated: March 31, 2025
Sponsor: Kyowa Kirin Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Aflibercept Injection

KHK4951

Clinical Study ID

NCT06116890
4951-002
  • Ages > 50
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntary written informed consent to participate in the study

  • Active subfoveal MNV (any subtype) or juxtafoveal/extrafoveal MNV secondary to AMDwith a subfoveal component related to the MNV activity in the study eye as assessedby FA (evidence of leakage) or SD-OCT (presence of fluid) judged by the centralreading center at screening

  • BCVA ETDRS letter score of 78 letters to 35 letters in the study eye as measured bythe ETDRS visual acuity chart at screening

  • CST ≥ 450 μm at screening

Exclusion

Exclusion Criteria:

  • Subretinal hemorrhage, fibrosis, or atrophy of > 50% of the total lesion area and/orthat 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 fromresolution 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 mayconfound 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 surgicalintervention 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 weeksprior 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 biosimilarswithin 12 weeks prior to Day 1. Previously treated patients who received thesemedications more than 12 weeks prior to Day 1 can be enrolled, but the patientsshould 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 eithereye

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Aflibercept Injection
Phase: 2
Study Start date:
January 31, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Eye Clinic Albury Wodonga

    Albury, New South Wales 2640
    Australia

    Active - Recruiting

  • Marsden Eye Specialists

    Parramatta, New South Wales
    Australia

    Active - Recruiting

  • Strathfield Retina Clinic

    Strathfield, New South Wales
    Australia

    Active - Recruiting

  • Sydney Eye Hospital

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Centre for Eye Research Australia

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Aichi Medical University Hospital - Ophthalmology

    Nagakute, Aichi 480-1195
    Japan

    Active - Recruiting

  • MIYAKE Eye Hospital

    Nagoya, Aichi 462-0825
    Japan

    Active - Recruiting

  • MIYAKE Eye Hospital

    Nagoya-shi, Aiti-ken
    Japan

    Site Not Available

  • Toho University Medical Center Sakura Hospital

    Sakura, Chiba 285-8741
    Japan

    Active - Recruiting

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime 790-8524
    Japan

    Suspended

  • Hayashi Eye Hospital - Ophthalmology

    Fukuoka-shi, Fukuoka 812-0011
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Hayashi Eye Hospital

    Fukuoka-shi, Fukuoka-ken
    Japan

    Site Not Available

  • Minamitohoku Eye Clinic

    Kōriyama, Fukushima 963-8563
    Japan

    Active - Recruiting

  • Minamitohoku Eye Clinic

    Koriyama-shi, Fukushima-ken
    Japan

    Site Not Available

  • Caress Sapporo Tokeidai Memorial Hospital

    Sapporo, Hokkaido 060-0031
    Japan

    Site Not Available

  • Kobe University Hospital - Ophthalmology

    Kobe, Hyôgo 650-0017
    Japan

    Site Not Available

  • Kozawa Eye Hospital and Diabetes Center

    Mito, Ibaraki 310-0845
    Japan

    Active - Recruiting

  • Kozawa Eye Hospital and Diabetes Center

    Mito-shi, Ibaraki-ken
    Japan

    Site Not Available

  • Kagawa University Hospital

    Kita-gun, Kanagawa 761-0793
    Japan

    Active - Recruiting

  • Shinshu University Hospital - Ophthalmology

    Matsumoto, Nagano 390-8621
    Japan

    Site Not Available

  • Nara Medical University Hospital - Ophthalmology

    Kashihara, Nara 634-8522
    Japan

    Site Not Available

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa 903-0215
    Japan

    Active - Recruiting

  • Kansai Medical University Medical Center

    Hirakata, Osaka 660-0892
    Japan

    Site Not Available

  • Kindai University Hospital

    Osakasayama, Osaka 577-8502
    Japan

    Site Not Available

  • Kindai University Hospital

    Osakasayama-shi, Osaka 577-8502
    Japan

    Site Not Available

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi 329-0498
    Japan

    Active - Recruiting

  • The University of Tokyo Hospital

    Bunkyō, Tokyo 113-8655
    Japan

    Active - Recruiting

  • The University of Tokyo Hospital

    Bunkyō-Ku, Tokyo 113-8655
    Japan

    Site Not Available

  • Nihon University Hospital

    Chiyoda, Tokyo 101-8309
    Japan

    Active - Recruiting

  • Nihon University Hospital

    Chiyoda-ku, Tokyo 101-8309
    Japan

    Site Not Available

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo 193-0998
    Japan

    Active - Recruiting

  • Tokyo Medical Center

    Meguro, Tokyo 152-8902
    Japan

    Active - Recruiting

  • Tokyo Medical Center

    Meguro-ku, Tokyo-to 152-8902
    Japan

    Site Not Available

  • Keio University Hospital - Ophthalmology

    Shinjuku, Tôkyô 160-8582
    Japan

    Active - Recruiting

  • Keio University Hospital - Ophthalmology

    Shinjuku-ku, Tôkyô 160-8582
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka, Ôsaka 545-0051
    Japan

    Active - Recruiting

  • Fukushima Medical University Hospital - Ophthalmology

    Fukushima, 960-1295
    Japan

    Active - Recruiting

  • Rakuwakai Otowa Hospital

    Kyoto, 607-8062
    Japan

    Active - Recruiting

  • Okayama University Hospital - Ophthalmology

    Okayama, 700-8558
    Japan

    Site Not Available

  • Saitama Red Cross Hospital

    Saitama, 330-8553
    Japan

    Active - Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, Dalseo-gu 42601
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggido
    Korea, Republic of

    Active - Recruiting

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggido 13496
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Hospital

    Daegu, Nam-gu 42415
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu 21565
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • Kim Eye Hospital

    Seoul, Seoul Teugbyeolsi 07301
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, Seoul Teugbyeolsi 02841
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Hospital

    Seoul, Seoul Teugbyeolsi 02447
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • Barnet Dulaney Perkins Eye Center - Phoenix

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Retina Associates Southwest, P.C.

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Win Retina

    Arcadia, California 91006
    United States

    Active - Recruiting

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • The Retina Partners

    Encino, California 91436
    United States

    Active - Recruiting

  • Retina Associates of Southern California

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Salehi Retina Institute, Inc

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Payam Amini

    Pasadena, California 91107
    United States

    Active - Recruiting

  • Retina Consultants of Southern CO

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • Blue Ocean Clinical Research West

    Clearwater, Florida 33761
    United States

    Active - Recruiting

  • Florida Eye Associates

    Melbourne, Florida 32901
    United States

    Active - Recruiting

  • Eye Associates of Pinellas

    Pinellas Park, Florida 33782
    United States

    Active - Recruiting

  • Ft. Lauderdale Eye Institute

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Retina Vitreous Associates of Florida - Saint Petersburg

    Saint Petersburg, Florida 33711
    United States

    Active - Recruiting

  • Southern Vitreoretinal Associates

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Center for Retina and Macular Disease - Ophthalmology

    Winter Haven, Florida 33880
    United States

    Active - Recruiting

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Massachusetts Eye and Ear

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Associated Retinal Consultants (ARC) P.C. - Opthalmology

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Retina Center of New Jersey

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Retina Vitreous Surgeons of Central NY, PC

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Long Island

    Oceanside, New York 11572
    United States

    Site Not Available

  • Retina Vitreous Center in Edmond Oklahoma

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Eye Health Northwest

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • EyeHealth Northwest

    Portland, Oregon 97225
    United States

    Site Not Available

  • Eye Care Specialists

    Kingston, Pennsylvania 18704
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute (RCA Network Site)

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Black Hills Regional Eye Institute - Ophthalmology

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Austin Clinical Research, LLC

    Austin, Texas 78750
    United States

    Active - Recruiting

  • Austin Retina Associates - Ophthalmology/Retina (RCA Network site)

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Texas Retina Associates

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Retinal Consultants of Texas- San Antonio (RCA Network site)

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas (RCA Network Site)

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas 76087
    United States

    Site Not Available

  • Retina Group of Washington

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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