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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06116890




Registration number
NCT06116890
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 Neovascular Age-Related Macular Degeneration
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 Neovascular Age-Related Macular Degeneration
Secondary ID [1] 0 0
4951-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-Related Macular Degeneration (nAMD) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

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 44 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 44 weeks until the end of the trial
Secondary outcome [1] 0 0
The number of aflibercept IVT
Timepoint [1] 0 0
For 44 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
44 weeks
Secondary outcome [3] 0 0
Change from baseline in retinal morphology as measured by SD-OCT
Timepoint [3] 0 0
44 weeks
Secondary outcome [4] 0 0
Change from baseline in MNV lesion area and total MNV leakage area as measured by FA
Timepoint [4] 0 0
44 Weeks

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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
31/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Eye Clinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
Marsden Eye Specialists - Parramatta
Recruitment hospital [3] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [4] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [5] 0 0
Adelaide Eye and Retina Centre - Adelaide
Recruitment hospital [6] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
- Parramatta
Recruitment postcode(s) [3] 0 0
- Strathfield
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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California
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Colorado
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Florida
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Georgia
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Massachusetts
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Michigan
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Nevada
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New Jersey
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New Mexico
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New York
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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United States of America
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Virginia
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Japan
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Aiti [Aichi]
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Japan
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Aiti
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Fukushima
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Japan
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Hokkaido
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Japan
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Hyôgo
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Japan
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Ibaraki
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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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Okinawa
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tochigi
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Japan
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Tokyo-to
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Japan
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Tokyo
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Japan
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Tôkyô
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Japan
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Kyoto
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Japan
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Okayama
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Japan
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Saitama
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Japan
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Ôsaka
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Korea, Republic of
State/province [41] 0 0
Daegu Gwang'yeogsi
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Korea, Republic of
State/province [42] 0 0
Gyeonggido
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Incheon Gwang'yeogsi
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Korea, Republic of
State/province [44] 0 0
Seoul Teugbyeolsi

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
[email protected]
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/NCT06116890