Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration
- Conditions
- Neovascular Age-Related Macular Degeneration (nAMD)
- Interventions
- Registration Number
- NCT06116890
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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 โฅ 450 ฮผm at screening
-
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 Visudyneยฎ, 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A KHK4951 KHK4951 High dose Arm C Aflibercept Injection KHK4951 Low dose Arm B Aflibercept Injection KHK4951 Middle dose Arm B KHK4951 KHK4951 Middle dose Arm A Aflibercept Injection KHK4951 High dose Arm C KHK4951 KHK4951 Low dose
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change from baseline in MNV lesion area and total MNV leakage area as measured by FA 44 Weeks Change from baseline in retinal morphology as measured by SD-OCT 44 weeks The number of aflibercept IVT For 44 weeks until the end of the trial Change from baseline in SHRM as measured by SD-OCT 44 weeks
Trial Locations
- Locations (84)
Barnet Dulaney Perkins Eye Center - Phoenix
๐บ๐ธMesa, Arizona, United States
Retina Associates Southwest, P.C.
๐บ๐ธTucson, Arizona, United States
Win Retina
๐บ๐ธArcadia, California, United States
Retina Vitreous Associates Medical Group
๐บ๐ธBeverly Hills, California, United States
The Retina Partners
๐บ๐ธEncino, California, United States
Salehi Retina Institute, Inc
๐บ๐ธHuntington Beach, California, United States
Payam Amini
๐บ๐ธPasadena, California, United States
Retina Consultants of Southern CO
๐บ๐ธColorado Springs, Colorado, United States
Blue Ocean Clinical Research West
๐บ๐ธClearwater, Florida, United States
Florida Eye Associates
๐บ๐ธMelbourne, Florida, United States
Eye Associates of Pinellas
๐บ๐ธPinellas Park, Florida, United States
Ft. Lauderdale Eye Institute
๐บ๐ธPlantation, Florida, United States
Retina Vitreous Associates of Florida - Saint Petersburg
๐บ๐ธSaint Petersburg, Florida, United States
Southern Vitreoretinal Associates
๐บ๐ธTallahassee, Florida, United States
Center for Retina and Macular Disease - Ophthalmology
๐บ๐ธWinter Haven, Florida, United States
Southeast Retina Center
๐บ๐ธAugusta, Georgia, United States
Massachusetts Eye and Ear
๐บ๐ธBoston, Massachusetts, United States
Associated Retinal Consultants (ARC) P.C. - Opthalmology
๐บ๐ธRoyal Oak, Michigan, United States
Sierra Eye Associates
๐บ๐ธReno, Nevada, United States
Retina Center of New Jersey
๐บ๐ธBloomfield, New Jersey, United States
Vision Research Center Eye Associates of New Mexico
๐บ๐ธAlbuquerque, New Mexico, United States
Retina Vitreous Surgeons of Central NY, PC
๐บ๐ธLiverpool, New York, United States
Ophthalmic Consultants of Long Island
๐บ๐ธOceanside, New York, United States
Retina Vitreous Center in Edmond Oklahoma
๐บ๐ธEdmond, Oklahoma, United States
Eye Health Northwest
๐บ๐ธPortland, Oregon, United States
Eye Care Specialists
๐บ๐ธKingston, Pennsylvania, United States
Charleston Neuroscience Institute (RCA Network Site)
๐บ๐ธLadson, South Carolina, United States
Black Hills Regional Eye Institute - Ophthalmology
๐บ๐ธRapid City, South Dakota, United States
Charles Retina Institute
๐บ๐ธGermantown, Tennessee, United States
Retina Research Institute of Texas
๐บ๐ธAbilene, Texas, United States
Austin Retina Associates - Ophthalmology/Retina (RCA Network site)
๐บ๐ธAustin, Texas, United States
Austin Clinical Research, LLC
๐บ๐ธAustin, Texas, United States
Retina Consultants of Texas
๐บ๐ธBellaire, Texas, United States
Texas Retina Associates
๐บ๐ธFort Worth, Texas, United States
Retinal Consultants of Texas- San Antonio (RCA Network site)
๐บ๐ธSan Antonio, Texas, United States
Retina Consultants of Texas (RCA Network Site)
๐บ๐ธThe Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
๐บ๐ธWillow Park, Texas, United States
Retina Group of Washington
๐บ๐ธFairfax, Virginia, United States
Eye Clinic Albury Wodonga
๐ฆ๐บAlbury, New South Wales, Australia
Marsden Eye Specialists
๐ฆ๐บParramatta, New South Wales, Australia
Strathfield Retina Clinic
๐ฆ๐บStrathfield, New South Wales, Australia
Sydney Eye Hospital
๐ฆ๐บSydney, New South Wales, Australia
Adelaide Eye and Retina Centre
๐ฆ๐บAdelaide, South Australia, Australia
Centre for Eye Research Australia
๐ฆ๐บEast Melbourne, Victoria, Australia
Aichi Medical University Hospital - Ophthalmology
๐ฏ๐ตNagakute, Aichi, Japan
MIYAKE Eye Hospital
๐ฏ๐ตNagoya, Aichi, Japan
Toho University Medical Center Sakura Hospital
๐ฏ๐ตSakura, Chiba, Japan
Matsuyama Red Cross Hospital
๐ฏ๐ตMatsuyama, Ehime, Japan
Hayashi Eye Hospital - Ophthalmology
๐ฏ๐ตFukuoka-shi, Fukuoka, Japan
Kurume University Hospital
๐ฏ๐ตKurume, Fukuoka, Japan
Minamitohoku Eye Clinic
๐ฏ๐ตKลriyama, Fukushima, Japan
Caress Sapporo Tokeidai Memorial Hospital
๐ฏ๐ตSapporo, Hokkaido, Japan
Kobe University Hospital - Ophthalmology
๐ฏ๐ตKobe, Hyรดgo, Japan
Kozawa Eye Hospital and Diabetes Center
๐ฏ๐ตMito, Ibaraki, Japan
Kagawa University Hospital
๐ฏ๐ตKita-gun, Kanagawa, Japan
Shinshu University Hospital - Ophthalmology
๐ฏ๐ตMatsumoto, Nagano, Japan
Nara Medical University Hospital - Ophthalmology
๐ฏ๐ตKashihara, Nara, Japan
University of the Ryukyus Hospital
๐ฏ๐ตNakagami-gun, Okinawa, Japan
Kansai Medical University Medical Center
๐ฏ๐ตHirakata, Osaka, Japan
Kindai University Hospital
๐ฏ๐ตOsakasayama, Osaka, Japan
Jichi Medical University Hospital
๐ฏ๐ตShimotsuke, Tochigi, Japan
The University of Tokyo Hospital
๐ฏ๐ตBunkyล, Tokyo, Japan
Nihon University Hospital
๐ฏ๐ตChiyoda, Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
๐ฏ๐ตHachiลji, Tokyo, Japan
Tokyo Medical Center
๐ฏ๐ตMeguro, Tokyo, Japan
Keio University Hospital - Ophthalmology
๐ฏ๐ตShinjuku, Tรดkyรด, Japan
Fukushima Medical University Hospital - Ophthalmology
๐ฏ๐ตFukushima, Japan
Rakuwakai Otowa Hospital
๐ฏ๐ตKyoto, Japan
Okayama University Hospital - Ophthalmology
๐ฏ๐ตOkayama, Japan
Saitama Red Cross Hospital
๐ฏ๐ตSaitama, Japan
Osaka Metropolitan University Hospital
๐ฏ๐ตOsaka, รsaka, Japan
Keimyung University Dongsan Hospital
๐ฐ๐ทDaegu, Dalseo-gu, Korea, Republic of
CHA Bundang Medical Center, CHA University
๐ฐ๐ทSeongnam-si, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital
๐ฐ๐ทSeongnam, Gyeonggido, Korea, Republic of
Yeungnam University Hospital
๐ฐ๐ทDaegu, Nam-gu, Korea, Republic of
Gachon University Gil Medical Center
๐ฐ๐ทIncheon, Namdong-gu, Korea, Republic of
Kyung Hee University Hospital
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Anam Hospital
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital, Yonsei University Health System
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of
Kim Eye Hospital
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of