- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06116890
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration
April 8, 2024 updated by: Kyowa Kirin, Inc.
A Phase 2, Multicenter, Randomized, Double-Masked, Parallel Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Neovascular Age-Related Macular Degeneration
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
180
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kyowa Kirin, Inc.
- Phone Number: 1-609-919-1100
- Email: kkd.clintrial.82@kyowakirin.com
Study Locations
-
-
New South Wales
-
Albury, New South Wales, Australia, 2640
- Recruiting
- Eye Clinic Albury Wodonga
-
Contact:
- Alan Luckie
-
Parramatta, New South Wales, Australia
- Not yet recruiting
- Marsden Eye Specialists
-
Contact:
- Yew Liang Terence Tan
-
Strathfield, New South Wales, Australia
- Not yet recruiting
- Strathfield Retina Clinic
-
Contact:
- James Wong
-
Sydney, New South Wales, Australia
- Not yet recruiting
- Sydney Eye Hospital
-
Contact:
- Samantha Fraser-Bell
-
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South Australia
-
Adelaide, South Australia, Australia, 5000
- Not yet recruiting
- Adelaide Eye and Retina Centre
-
Contact:
- Jagjit Gilhotra
-
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Victoria
-
East Melbourne, Victoria, Australia, 3002
- Not yet recruiting
- Centre for Eye Research Australia
-
Contact:
- Sanjeewa Wickremasinghe
-
-
-
-
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Fukushima, Japan, 960-1295
- Not yet recruiting
- Fukushima Medical University Hospital - Ophthalmology
-
Contact:
- Tetsuju Sekiryu
-
Kyoto, Japan, 607-8062
- Not yet recruiting
- Rakuwakai Otowa Hospital
-
Contact:
- Noriko Miyamoto
-
Okayama, Japan, 700-8558
- Not yet recruiting
- Okayama University Hospital - Ophthalmology
-
Contact:
- Mio Hosokawa
-
Saitama, Japan, 330-8553
- Not yet recruiting
- Saitama Red Cross Hospital
-
Contact:
- Kiyoshi Ishii
-
-
Aiti
-
Nagoya, Aiti, Japan, 462-0825
- Not yet recruiting
- MIYAKE Eye Hospital
-
Contact:
- Kondo Nagako
-
-
Aiti [Aichi]
-
Nagakute, Aiti [Aichi], Japan, 480-1195
- Not yet recruiting
- Aichi Medical University Hospital - Ophthalmology
-
Contact:
- Yuichiro Ishida
-
-
Chiba
-
Sakura, Chiba, Japan, 285-8741
- Not yet recruiting
- Toho University Medical Center Sakura Hospital
-
Contact:
- Fumihiko Yagi
-
-
Fukuoka
-
Fukuoka-shi, Fukuoka, Japan, 812-0011
- Recruiting
- Hayashi Eye Hospital - Ophthalmology
-
Contact:
- Ken Hayashi
-
Kurume, Fukuoka, Japan, 830-0011
- Not yet recruiting
- Kurume University Hospital
-
Contact:
- Shigeo Yoshida
-
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Fukushima
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Kōriyama, Fukushima, Japan, 963-8563
- Not yet recruiting
- Minamitohoku Eye Clinic
-
Contact:
- Namie Kobayashi
-
-
Hyôgo
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Kobe, Hyôgo, Japan, 650-0017
- Not yet recruiting
- Kobe University Hospital - Ophthalmology
-
Contact:
- Sentaro Kusuhara
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Ibaraki
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Mito, Ibaraki, Japan, 310-0845
- Recruiting
- Kozawa Eye Hospital and Diabetes Center
-
Contact:
- Takashi Hiroe
-
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Nagano
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Matsumoto, Nagano, Japan, 390-8621
- Not yet recruiting
- Shinshu University Hospital - Ophthalmology
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Contact:
- Noriko Yoshida
-
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Nara
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Kashihara, Nara, Japan, 634-8522
- Not yet recruiting
- Nara Medical University Hospital - Ophthalmology
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Contact:
- Tetsuo Ueda
-
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Okinawa
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Nakagami-gun, Okinawa, Japan, 903-0215
- Not yet recruiting
- University of the Ryukyus Hospital
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Contact:
- Hideki Koizumi
-
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Osaka
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Hirakata, Osaka, Japan, 660-0892
- Not yet recruiting
- Kansai Medical University Medical Center
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Contact:
- Yoshimi Nagai
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Osakasayama-shi, Osaka, Japan, 577-8502
- Not yet recruiting
- Kindai University Hospital
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Contact:
- Shunji Kusaka
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Shizuoka
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Matsuyama, Shizuoka, Japan, 790-8524
- Suspended
- Matsuyama Red Cross Hospital
-
-
Tochigi
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Shimotsuke, Tochigi, Japan, 329-0498
- Not yet recruiting
- Jichi Medical University Hospital
-
Contact:
- Hidenori Takahas
-
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Tokyo
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Bunkyō-Ku, Tokyo, Japan, 113-8655
- Not yet recruiting
- The University of Tokyo Hospital
-
Contact:
- Keiko Azuma
-
Chiyoda-ku, Tokyo, Japan, 101-8309
- Recruiting
- Nihon University Hospital
-
Contact:
- Ryusaburo Mori
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Hachiōji, Tokyo, Japan, 193-0998
- Not yet recruiting
- Tokyo Medical University Hachioji Medical Center
-
Contact:
- Masahiko Shimura
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Kita-gun, Tokyo, Japan, 761-0793
- Not yet recruiting
- Kagawa University Hospital
-
Contact:
- Kiyoshi Suzuma
-
-
Tokyo-to
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Meguro-ku, Tokyo-to, Japan, 152-8902
- Not yet recruiting
- Tokyo Medical Center
-
Contact:
- Kunihiko Akiyama
-
-
Tôkyô
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Shinjuku-ku, Tôkyô, Japan, 160-8582
- Not yet recruiting
- Keio University Hospital - Ophthalmology
-
Contact:
- Hajime Shinoda
-
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Ôsaka
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Osaka, Ôsaka, Japan, 545-0051
- Not yet recruiting
- Osaka Metropolitan University Hospital
-
Contact:
- Shigeru Honda
-
-
-
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Daegu Gwang'yeogsi
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Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 42601
- Not yet recruiting
- Keimyung University Dongsan Hospital
-
Contact:
- Yu Cheol Kim
-
Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 42415
- Recruiting
- Yeungnam University Hospital
-
Contact:
- Min Sagong
-
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Gyeonggido
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Seongnam, Gyeonggido, Korea, Republic of
- Not yet recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Se Joon Woo
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Seongnam-si, Gyeonggido, Korea, Republic of, 13496
- Not yet recruiting
- CHA Bundang Medical Center, CHA University
-
Contact:
- Youngje Sung
-
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Incheon Gwang'yeogsi
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Incheon, Incheon Gwang'yeogsi, Korea, Republic of, 21565
- Not yet recruiting
- Gachon University Gil Medical Center
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Contact:
- Dong-Heun Nam
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
- Not yet recruiting
- Seoul National University Hospital
-
Contact:
- Kyu Hyung Park
-
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
- Not yet recruiting
- Asan Medical Center
-
Contact:
- Young Hee Yoon
-
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
- Not yet recruiting
- Samsung medical center
-
Contact:
- Se Woong Kang
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02841
- Not yet recruiting
- Korea University Anam Hospital
-
Contact:
- Jaeryung Oh
-
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
- Not yet recruiting
- Severance Hospital, Yonsei University Health System
-
Contact:
- Christopher Lee
-
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07301
- Not yet recruiting
- Kim Eye Hospital
-
Contact:
- Jae Hui Kim
-
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02447
- Not yet recruiting
- Kyung Hee University Hospital
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Contact:
- Seung Young Yu
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Seoul, Seoul Teugbyeolsi, Korea, Republic of
- Not yet recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Contact:
- Young-Hoon Park
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Arizona
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Mesa, Arizona, United States, 85206
- Not yet recruiting
- Barnet Dulaney Perkins Eye Center - Phoenix
-
Contact:
- Jordan Graff
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Tucson, Arizona, United States, 85710
- Not yet recruiting
- Retina Associates Southwest, P.C.
-
Contact:
- Cameron Javid
-
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California
-
Arcadia, California, United States, 91006
- Recruiting
- Win Retina
-
Contact:
- Peter Win
-
Beverly Hills, California, United States, 90211
- Not yet recruiting
- Retina Vitreous Associates Medical Group
-
Contact:
- Firas Rahhal
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Encino, California, United States, 91436
- Not yet recruiting
- The Retina Partners
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Contact:
- Hajir Dadgostar
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Huntington Beach, California, United States, 92647
- Not yet recruiting
- Salehi Retina Institute, Inc
-
Contact:
- Hani Salehi-Had
-
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Colorado
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Colorado Springs, Colorado, United States, 80909
- Recruiting
- Retina Consultants of Southern CO
-
Contact:
- Cecinio Ronquillo
-
-
Florida
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Clearwater, Florida, United States, 33761
- Not yet recruiting
- Blue Ocean Clinical Research West
-
Contact:
- Dana Deupree
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Melbourne, Florida, United States, 32901
- Recruiting
- Florida Eye Associates
-
Contact:
- Vrinda Hershberger
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Pinellas Park, Florida, United States, 33782
- Recruiting
- Eye Associates of Pinellas
-
Contact:
- Jason Handza
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Plantation, Florida, United States, 33324
- Not yet recruiting
- Ft. Lauderdale Eye Institute
-
Contact:
- Stuart Burgess
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Saint Petersburg, Florida, United States, 33711
- Not yet recruiting
- Retina Vitreous Associates of Florida - Saint Petersburg
-
Contact:
- David Eichenbaum
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Winter Haven, Florida, United States, 33880
- Recruiting
- Center for Retina and Macular Disease - Ophthalmology
-
Contact:
- Adam Berger
-
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Georgia
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Augusta, Georgia, United States, 30909
- Not yet recruiting
- Southeast Retina Center
-
Contact:
- Dennis Marcus
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Not yet recruiting
- Massachusetts Eye and Ear
-
Contact:
- Mohammad Dahrouj
-
-
Michigan
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Royal Oak, Michigan, United States, 48073
- Not yet recruiting
- Associated Retinal Consultants (ARC) P.C. - Opthalmology
-
Contact:
- Antonio Capone
-
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Nevada
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Reno, Nevada, United States, 89502
- Not yet recruiting
- Sierra Eye Associates
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Contact:
- Arshad Khanani
-
-
New Jersey
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Bloomfield, New Jersey, United States, 07003
- Not yet recruiting
- Retina Center of New Jersey
-
Contact:
- Patrick Higgins
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87109
- Recruiting
- Vision Research Center Eye Associates of New Mexico
-
Contact:
- John Pitcher
-
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New York
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Liverpool, New York, United States, 13088
- Not yet recruiting
- Retina Vitreous Surgeons of Central NY, PC
-
Contact:
- Jamin Brown
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Oceanside, New York, United States, 11572
- Not yet recruiting
- Ophthalmic Consultants of Long Island
-
Contact:
- Ketan Laud
-
-
Oklahoma
-
Edmond, Oklahoma, United States, 73013
- Not yet recruiting
- Retina Vitreous Center in Edmond Oklahoma
-
Contact:
- Sandeep Shah
-
-
Oregon
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Portland, Oregon, United States, 97225
- Recruiting
- Eye Health Northwest
-
Contact:
- Christopher Aderman
-
-
Pennsylvania
-
Kingston, Pennsylvania, United States, 18704
- Recruiting
- Eye Care Specialists
-
Contact:
- Erik Kruger
-
-
South Carolina
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Ladson, South Carolina, United States, 29456
- Not yet recruiting
- Charleston Neuroscience Institute (RCA Network Site)
-
Contact:
- Daniel Alfaro
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- Not yet recruiting
- Black Hills Regional Eye Institute - Ophthalmology
-
Contact:
- Prema Abraham
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- Not yet recruiting
- Charles Retina Institute
-
Contact:
- Stephen Huddleston
-
-
Texas
-
Abilene, Texas, United States, 79606
- Not yet recruiting
- Retina Research Institute of Texas
-
Contact:
- Sunil Patel
-
Austin, Texas, United States, 78705
- Recruiting
- Austin Retina Associates - Ophthalmology/Retina (RCA Network site)
-
Contact:
- Robert Wong
-
Austin, Texas, United States, 78750
- Not yet recruiting
- Austin Clinical Research, LLC
-
Contact:
- Brian Berger
-
Bellaire, Texas, United States, 77401
- Not yet recruiting
- Retina Consultants of Texas
-
Contact:
- David Brown
-
Fort Worth, Texas, United States, 76104
- Not yet recruiting
- Texas Retina Associates
-
Contact:
- Patrick Williams
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San Antonio, Texas, United States, 78240
- Not yet recruiting
- Retinal Consultants of Texas- San Antonio (RCA Network site)
-
Contact:
- Richard Lane
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The Woodlands, Texas, United States, 77384
- Recruiting
- Retina Consultants of Texas (RCA Network Site)
-
Contact:
- Charles Wykoff
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Willow Park, Texas, United States, 76087
- Not yet recruiting
- Strategic Clinical Research Group, LLC
-
Contact:
- Seong Lee
-
-
Virginia
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Fairfax, Virginia, United States, 22031
- Not yet recruiting
- Retina Group of Washington
-
Contact:
- Joshua Levinson
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
KHK4951 High dose
|
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
KHK4951 eye drop for 44 weeks until end of the trial
|
Experimental: Arm B
KHK4951 Middle dose
|
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
KHK4951 eye drop for 44 weeks until end of the trial
|
Experimental: Arm C
KHK4951 Low dose
|
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
KHK4951 eye drop for 44 weeks until end of the trial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
Time Frame: For 44 weeks until the end of the trial
|
For 44 weeks until the end of the trial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of aflibercept IVT
Time Frame: For 44 weeks until the end of the trial
|
For 44 weeks until the end of the trial
|
Change from baseline in SHRM as measured by SD-OCT
Time Frame: 44 weeks
|
44 weeks
|
Change from baseline in retinal morphology as measured by SD-OCT
Time Frame: 44 weeks
|
44 weeks
|
Change from baseline in MNV lesion area and total MNV leakage area as measured by FA
Time Frame: 44 Weeks
|
44 Weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events
Time Frame: For 44 weeks until the end of the trial
|
For 44 weeks until the end of the trial
|
Serum KHK4951 concentration
Time Frame: 44 Weeks
|
44 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sotaro Takigawa, Kyowa Kirin Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2024
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
October 31, 2023
First Submitted That Met QC Criteria
October 31, 2023
First Posted (Actual)
November 3, 2023
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 8, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4951-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowakirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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