Clinical trial NCT06116916: Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
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 Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Macular Edema (DME)
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.


Eligibility criteria: Inclusion Criteria:

* Voluntary written informed consent to participate in the study
* In Korea, participants must be 19 years or older to be enrolled
* BCVA ETDRS letter score of 78 letters to 35 letters as measured by the ETDRS visual acuity chart in the study eye at screening
* 500 μm ≥ CST ≥ 325 μm in the study eye at screening
* HbA1c ≤ 11% at screening

Exclusion Criteria:

* Any signs of proliferative diabetic retinopathy in the study eye
* History of rubeosis 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 DME that may confound assessment of the macula or affect central vision in the study eye
* History of the following therapies in the study eye

  * History of vitrectomy surgery, submacular surgery, or other surgical intervention for DME
  * Periocular or intraocular (sub-Tenon or IVT) corticosteroids within 12 weeks prior to Day 1 corticosteroids
  * Previous intraocular device implantation except PC-IOL
  * Laser (any type) to the macular area within 12 weeks prior to Day 1
  * Peripheral retinal photocoagulation therapy within 12 weeks prior to Day 1
  * 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 DME within 3 years prior to Day 1
  * Previous use of Ozurdex® or Iluvien® implant
* 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

Primary outcomes:
measure: Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
timeFrame: For 36 weeks until the end of the trial
Secondary outcomes:
measure: The number of aflibercept IVT
timeFrame: For 36 weeks until the end of the trial
measure: Change from baseline in SHRM as measured by SD-OCT
timeFrame: 36 Weeks
measure: Change from baseline in retinal morphology as measured by SD-OCT
timeFrame: 36 Weeks
measure: Change from baseline in leakage as measured by FA
timeFrame: 36 Weeks
Other outcomes:
measure: Number of participants with adverse events
timeFrame: For 36 weeks until the end of the trial
measure: Serum KHK4951 concentration
timeFrame: 36 Weeks
Locations:
city: Mesa
country: United States
facility: Barnet Dulaney Perkins Eye Center - Phoenix
state: Arizona
city: Tucson
country: United States
facility: Retina Associates Southwest, P.C.
state: Arizona
city: Arcadia
country: United States
facility: Win Retina
state: California
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Huntington Beach
country: United States
facility: Salehi Retina Institute, Inc
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group Inc
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern CO
state: Colorado
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research West
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Pinellas Park
country: United States
facility: Eye Associates of Pinellas
state: Florida
city: Plantation
country: United States
facility: Ft. Lauderdale Eye Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida - Saint Petersburg
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Associates
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease - Ophthalmology
state: Florida
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists - Hagerstown
state: Maryland
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Vision Research Center Eye Associates of New Mexico
state: New Mexico
city: Liverpool
country: United States
facility: Retina Vitreous Surgeons of Central NY, PC
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Edmond
country: United States
facility: Retina Vitreous Center in Edmond Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Bethlehem
country: United States
facility: Wills Eye Health System
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Charleston
country: United States
facility: Retina Consultants of Charleston - (RCA Network Site)
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute (RCA Network Site)
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute - Ophthalmology
state: South Dakota
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates - Ophthalmology/Retina (RCA Network site)
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research, LLC
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Fort Worth
country: United States
facility: Texas Retina Associates
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of Texas- San Antonio (RCA Network site)
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas (RCA Network Site)
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Burlington
country: United States
facility: University of Vermont Fletcher Allen Health Care
state: Vermont
city: Fairfax
country: United States
facility: Retina Group of Washington
state: Virginia
city: Albury
country: Australia
facility: Eye Clinic Albury Wodonga
state: New South Wales
city: Liverpool
country: Australia
facility: South West Retina
state: New South Wales
city: Parramatta
country: Australia
facility: Marsden Eye Specialists
state: New South Wales
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic & Day Surgery
state: New South Wales
city: Adelaide
country: Australia
facility: Adelaide Eye and Retina Centre
state: South Australia
city: Hobart
country: Australia
facility: Hobart Eye Surgeons
state: Tasmania
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital - Ophthalmology
state: Aichi
city: Nagoya
country: Japan
facility: MIYAKE Eye Hospital
state: Aichi
city: Sakura
country: Japan
facility: Toho University Medical Center Sakura Hospital
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Koriyama
country: Japan
facility: Minamitohoku Eye Clinic
state: Fukushima
city: Sapporo
country: Japan
facility: Caress Sapporo Tokeidai Memorial Hospital
state: Hokkaidô
city: Kobe
country: Japan
facility: Kobe University Hospital - Ophthalmology
state: Hyôgo
city: Mito
country: Japan
facility: Kozawa Eye Hospital and Diabetes Center
state: Ibaraki
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Matsumoto
country: Japan
facility: Shinshu University Hospital - Ophthalmology
state: Nagano
city: Kashihara
country: Japan
facility: Nara Medical University Hospital - Ophthalmology
state: Nara
city: Hirakata
country: Japan
facility: Kansai Medical University Medical Center
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Susono
country: Japan
facility: Muramatsu Clinic Muramatsu Eye Clinic - Ophthalmology
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Chiyoda
country: Japan
facility: Nihon University Hospital
state: Tokyo
city: Hachiōji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
state: Tokyo
city: Meguro
country: Japan
facility: Tokyo Medical Center
state: Tokyo
city: Shinjuku
country: Japan
facility: Keio University Hospital - Ophthalmology
state: Tokyo
city: Fukuoka
country: Japan
facility: Hayashi Eye Hospital - Ophthalmology
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital - Ophthalmology
city: Kyoto
country: Japan
facility: Rakuwakai Otowa Hospital
city: Saitama
country: Japan
facility: Saitama Red Cross Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
state: Ôsaka
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Dalseo-gu
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Gudeok-ro
city: Seongam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Nam-gu
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kim Eye hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ of KOR, SSMH
Study officials:
affiliation: Kyowa Kirin Co., Ltd.
name: Sotaro Takigawa
role: STUDY_DIRECTOR
References: