A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients With Diabetic Macular Edema

Sponsor

Kyowa Kirin, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06116916

Collaborator

(none)

150

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema (DME)	Drug: KHK4951 Drug: Aflibercept Injection	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A KHK4951 High dose	Drug: KHK4951 KHK4951 eye drop for 36 weeks until end of the trial Drug: Aflibercept Injection Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Experimental: Arm B KHK4951 Middle dose	Drug: KHK4951 KHK4951 eye drop for 36 weeks until end of the trial Drug: Aflibercept Injection Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol
Experimental: Arm C KHK4951 Low dose	Drug: KHK4951 KHK4951 eye drop for 36 weeks until end of the trial Drug: Aflibercept Injection Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Arm

Intervention/Treatment

Experimental: Arm A

KHK4951 High dose

Drug: KHK4951

KHK4951 eye drop for 36 weeks until end of the trial

Drug: Aflibercept Injection

Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Experimental: Arm B

KHK4951 Middle dose

Drug: KHK4951

KHK4951 eye drop for 36 weeks until end of the trial

Drug: Aflibercept Injection

Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Experimental: Arm C

KHK4951 Low dose

Drug: KHK4951

KHK4951 eye drop for 36 weeks until end of the trial

Drug: Aflibercept Injection

Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol

Outcome Measures

Primary Outcome Measures

Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline [For 36 weeks until the end of the trial]

Secondary Outcome Measures

The number of aflibercept IVT [For 36 weeks until the end of the trial]
Change from baseline in SHRM as measured by SD-OCT [36 Weeks]
Change from baseline in retinal morphology as measured by SD-OCT [36 Weeks]
Change from baseline in leakage as measured by FA [36 Weeks]

Other Outcome Measures

Number of participants with adverse events [For 36 weeks until the end of the trial]
Serum KHK4951 concentration [36 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Voluntary written informed consent to participate in the study
BCVA ETDRS letter score of 73 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
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 any IVT anti-VEGF drugs
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Win Retina	Arcadia	California	United States	91006
2	The Retina Partners	Encino	California	United States	91436
3	Retina Associates of Southern California	Huntington Beach	California	United States	92647
4	Retina Consultants of Southern California	Redlands	California	United States	92374
5	Blue Ocean Clinical Research West	Clearwater	Florida	United States	33761
6	Eye Associates of Pinellas	Pinellas Park	Florida	United States	33782
7	Retina Vitreous Associates of Florida - Saint Petersburg	Saint Petersburg	Florida	United States	33711
8	Mid Atlantic Retina Specialists - Hagerstown	Hagerstown	Maryland	United States	21740
9	Vision Research Center Eye Associates of New Mexico	Albuquerque	New Mexico	United States	87109
10	Retina Vitreous Surgeons of Central NY, PC	Liverpool	New York	United States	13088
11	Ophthalmic Consultants of Long Island	Oceanside	New York	United States	11572
12	Retina Vitreous Center in Edmond Oklahoma	Edmond	Oklahoma	United States	73013
13	EyeHealth Northwest	Portland	Oregon	United States	97225
14	Eye Care Specialists	Kingston	Pennsylvania	United States	18704
15	Retina Consultants of Texas	Bellaire	Texas	United States	77401
16	Retinal Consultants of Texas- San Antonio (RCA Network site)	San Antonio	Texas	United States	78240
17	Eye Clinic Albury Wodonga	Albury	New South Wales	Australia
18	Marsden Eye Specialists	Parramatta	New South Wales	Australia
19	Strathfield Retina Clinic	Strathfield	New South Wales	Australia
20	Sydney Eye Hospital	Sydney	New South Wales	Australia
21	MIYAKE Eye Hospital	Nagoya-shi	Aiti-ken	Japan
22	Hayashi Eye Hospital	Fukuoka-shi	Fukuoka-ken	Japan
23	Minamitohoku Eye Clinic	Koriyama-shi	Fukushima-ken	Japan
24	Kozawa Eye Hospital and Diabetes Center	Mito-shi	Ibaraki-ken	Japan
25	Nihon University Hospital	Chiyoda-ku	Tokyo-to	Japan
26	Tokyo Medical Center	Meguro-ku	Tokyo-to	Japan
27	Seoul National University Bundang Hospital	Seongam	Gyeonggido	Korea, Republic of
28	Gachon University Gil Medical Center	Incheon	Incheon Gwang'yeogsi,	Korea, Republic of
29	Korea University Anam Hospital	Seoul	Seoul Teugbyeolsi	Korea, Republic of
30	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi	Korea, Republic of

Sponsors and Collaborators

Kyowa Kirin, Inc.

Investigators

Study Director: Shinsaku Kihara, Kyowa Kirin Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kyowa Kirin, Inc.

ClinicalTrials.gov Identifier:

NCT06116916

Other Study ID Numbers:

4951-003

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Edema

Edema

Aflibercept

Study Results

No Results Posted as of Nov 3, 2023