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

Neovascular Age-Related Macular Degeneration (nAMD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116890
• Other study ID #: 4951-002
• Status: Recruiting
• Phase: Phase 2
• Start date: January 31, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: Kyowa Kirin, Inc.
• Phone: 1-609-919-1100
• Email: kkd.clintrial.82[@]kyowakirin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration (nAMD)
• Wet Macular Degeneration

Intervention

Drug:
• KHK4951
KHK4951 eye drop for 44 weeks until end of the trial
• Aflibercept Injection
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Locations

Country	Name	City	State
Australia	Adelaide Eye and Retina Centre	Adelaide	South Australia
Australia	Eye Clinic Albury Wodonga	Albury	New South Wales
Australia	Centre for Eye Research Australia	East Melbourne	Victoria
Australia	Marsden Eye Specialists	Parramatta	New South Wales
Australia	Strathfield Retina Clinic	Strathfield	New South Wales
Australia	Sydney Eye Hospital	Sydney	New South Wales
Japan	The University of Tokyo Hospital	Bunkyo-Ku	Tokyo
Japan	Nihon University Hospital	Chiyoda-ku	Tokyo
Japan	Hayashi Eye Hospital - Ophthalmology	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital - Ophthalmology	Fukushima
Japan	Tokyo Medical University Hachioji Medical Center	Hachioji	Tokyo
Japan	Kansai Medical University Medical Center	Hirakata	Osaka
Japan	Nara Medical University Hospital - Ophthalmology	Kashihara	Nara
Japan	Kagawa University Hospital	Kita-gun	Tokyo
Japan	Kobe University Hospital - Ophthalmology	Kobe	Hyôgo
Japan	Minamitohoku Eye Clinic	Koriyama	Fukushima
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Rakuwakai Otowa Hospital	Kyoto
Japan	Shinshu University Hospital - Ophthalmology	Matsumoto	Nagano
Japan	Matsuyama Red Cross Hospital	Matsuyama	Shizuoka
Japan	Tokyo Medical Center	Meguro-ku	Tokyo-to
Japan	Kozawa Eye Hospital and Diabetes Center	Mito	Ibaraki
Japan	Aichi Medical University Hospital - Ophthalmology	Nagakute	Aiti [Aichi]
Japan	MIYAKE Eye Hospital	Nagoya	Aiti
Japan	University of the Ryukyus Hospital	Nakagami-gun	Okinawa
Japan	Okayama University Hospital - Ophthalmology	Okayama
Japan	Osaka Metropolitan University Hospital	Osaka	Ôsaka
Japan	Kindai University Hospital	Osakasayama-shi	Osaka
Japan	Saitama Red Cross Hospital	Saitama
Japan	Toho University Medical Center Sakura Hospital	Sakura	Chiba
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Keio University Hospital - Ophthalmology	Shinjuku-ku	Tôkyô
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Daegu Gwang'yeogsi
Korea, Republic of	Yeungnam University Hospital	Daegu	Daegu Gwang'yeogsi
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Incheon Gwang'yeogsi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggido
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Kim Eye Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Kyung Hee University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul	Seoul Teugbyeolsi
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Vision Research Center Eye Associates of New Mexico	Albuquerque	New Mexico
United States	Win Retina	Arcadia	California
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Clinical Research, LLC	Austin	Texas
United States	Austin Retina Associates - Ophthalmology/Retina (RCA Network site)	Austin	Texas
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Retina Vitreous Associates Medical Group	Beverly Hills	California
United States	Retina Center of New Jersey	Bloomfield	New Jersey
United States	Massachusetts Eye and Ear	Boston	Massachusetts
United States	Blue Ocean Clinical Research West	Clearwater	Florida
United States	Retina Consultants of Southern CO	Colorado Springs	Colorado
United States	Retina Vitreous Center in Edmond Oklahoma	Edmond	Oklahoma
United States	The Retina Partners	Encino	California
United States	Retina Group of Washington	Fairfax	Virginia
United States	Texas Retina Associates	Fort Worth	Texas
United States	Charles Retina Institute	Germantown	Tennessee
United States	Salehi Retina Institute, Inc	Huntington Beach	California
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Charleston Neuroscience Institute (RCA Network Site)	Ladson	South Carolina
United States	Retina Vitreous Surgeons of Central NY, PC	Liverpool	New York
United States	Florida Eye Associates	Melbourne	Florida
United States	Barnet Dulaney Perkins Eye Center - Phoenix	Mesa	Arizona
United States	Ophthalmic Consultants of Long Island	Oceanside	New York
United States	Payam Amini	Pasadena	California
United States	Eye Associates of Pinellas	Pinellas Park	Florida
United States	Ft. Lauderdale Eye Institute	Plantation	Florida
United States	Eye Health Northwest	Portland	Oregon
United States	Black Hills Regional Eye Institute - Ophthalmology	Rapid City	South Dakota
United States	Sierra Eye Associates	Reno	Nevada
United States	Associated Retinal Consultants (ARC) P.C. - Opthalmology	Royal Oak	Michigan
United States	Retina Vitreous Associates of Florida - Saint Petersburg	Saint Petersburg	Florida
United States	Retinal Consultants of Texas- San Antonio (RCA Network site)	San Antonio	Texas
United States	Retina Consultants of Texas (RCA Network Site)	The Woodlands	Texas
United States	Retina Associates Southwest, P.C.	Tucson	Arizona
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas
United States	Center for Retina and Macular Disease - Ophthalmology	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events		For 44 weeks until the end of the trial
Other	Serum KHK4951 concentration		44 Weeks
Primary	Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline		For 44 weeks until the end of the trial
Secondary	The number of aflibercept IVT		For 44 weeks until the end of the trial
Secondary	Change from baseline in SHRM as measured by SD-OCT		44 weeks
Secondary	Change from baseline in retinal morphology as measured by SD-OCT		44 weeks
Secondary	Change from baseline in MNV lesion area and total MNV leakage area as measured by FA		44 Weeks