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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/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 = 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
* 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
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
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Massachusetts
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United States of America
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Michigan
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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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New York
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United States of America
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Oklahoma
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Oregon
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United States of America
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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
State/province [20] 0 0
Aichi
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Japan
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Chiba
Country [22] 0 0
Japan
State/province [22] 0 0
Ehime
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Japan
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Fukuoka
Country [24] 0 0
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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Kanagawa
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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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Tochigi
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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
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Dalseo-gu
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
State/province [42] 0 0
Nam-gu
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Korea, Republic of
State/province [43] 0 0
Namdong-gu
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul Teugbyeolsi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kyowa Kirin Co., Ltd.
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


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