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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06116916




Registration number
NCT06116916
Ethics application status
Date submitted
31/10/2023
Date registered
3/11/2023

Titles & IDs
Public title
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
Scientific 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
Secondary ID [1] 0 0
4951-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema (DME) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KHK4951
Treatment: Drugs - Aflibercept Injection

Experimental: Arm A - KHK4951 High dose

Experimental: Arm B - KHK4951 Middle dose

Experimental: Arm C - KHK4951 Low dose


Treatment: Drugs: KHK4951
KHK4951 eye drop for 36 weeks until end of the trial

Treatment: Drugs: Aflibercept Injection
Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
Timepoint [1] 0 0
For 36 weeks until the end of the trial
Secondary outcome [1] 0 0
The number of aflibercept IVT
Timepoint [1] 0 0
For 36 weeks until the end of the trial
Secondary outcome [2] 0 0
Change from baseline in SHRM as measured by SD-OCT
Timepoint [2] 0 0
36 Weeks
Secondary outcome [3] 0 0
Change from baseline in retinal morphology as measured by SD-OCT
Timepoint [3] 0 0
36 Weeks
Secondary outcome [4] 0 0
Change from baseline in leakage as measured by FA
Timepoint [4] 0 0
36 Weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
* 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 panretinal photocoagulation treatment
* Previous treatment with IVT anti-VEGF drugs other than ranibizumab, bevacizumab, aflibercept 2 mg, and their biosimilars
* Previous treatment with ranibizumab, bevacizumab, aflibercept 2 mg, or their biosimilars within 12 weeks before being enrolled to the study.If a previously treated patient is enrolled, the patient should be diagnosed with DME within 3 years before being enrolled to the study.
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Eye Clinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
South West Retina - Liverpool
Recruitment hospital [3] 0 0
Marsden Eye Specialists - Parramatta
Recruitment hospital [4] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [5] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [6] 0 0
Sydney Retina Clinic & Day Surgery - Sydney
Recruitment hospital [7] 0 0
Adelaide Eye and Retina Centre - Adelaide
Recruitment hospital [8] 0 0
Hobart Eye Surgeons - Hobart
Recruitment hospital [9] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment postcode(s) [1] 0 0
02640 - Albury
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
02150 - Parramatta
Recruitment postcode(s) [4] 0 0
2135 - Strathfield
Recruitment postcode(s) [5] 0 0
2000 - Sydney
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7008 - Hobart
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
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Florida
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United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Virginia
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Japan
State/province [18] 0 0
Aiti-ken
Country [19] 0 0
Japan
State/province [19] 0 0
Aiti
Country [20] 0 0
Japan
State/province [20] 0 0
Chiba
Country [21] 0 0
Japan
State/province [21] 0 0
Fukuoka
Country [22] 0 0
Japan
State/province [22] 0 0
Fukushima
Country [23] 0 0
Japan
State/province [23] 0 0
Hokkaidô [Hokkaido]
Country [24] 0 0
Japan
State/province [24] 0 0
Hyôgo
Country [25] 0 0
Japan
State/province [25] 0 0
Ibaraki
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Japan
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Kagawa
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Japan
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Nagano
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Japan
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Nara
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Japan
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Osaka
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Japan
State/province [30] 0 0
Shizuoka
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Japan
State/province [31] 0 0
Tochigi
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Japan
State/province [32] 0 0
Tokyo
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Japan
State/province [33] 0 0
Kyoto
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Japan
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Saitama
Country [35] 0 0
Japan
State/province [35] 0 0
Ôsaka
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Busan Gwang'yeogsi
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Daegu Gwang'yeogsi
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Gyeonggido
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Korea, Republic of
State/province [39] 0 0
Incheon Gwang'yeogsi
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Korea, Republic of
State/province [40] 0 0
Seoul Teugbyeolsi
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kyowa Kirin, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sotaro Takigawa
Address 0 0
Kyowa Kirin Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kyowa Kirin, Inc.
Address 0 0
Country 0 0
Phone 0 0
+1-609-919-1100
Fax 0 0
Email 0 0
kkd.clintrial.82@kyowakirin.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06116916