Clincosm LogoSign in Get a demo

A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration

Sponsor
Kyowa Kirin, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06116890
Collaborator
(none)
180
Enrollment
28
Locations
3
Arms
25
Anticipated Duration (Months)
6.4
Patients Per Site
0.3
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 nAMD.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 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 Neovascular Age-Related Macular Degeneration
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 44 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 44 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 44 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

  1. Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline [For 44 weeks until the end of the trial]

Secondary Outcome Measures

  1. The number of aflibercept IVT [For 44 weeks until the end of the trial]

  2. Change from baseline in SHRM as measured by SD-OCT [44 weeks]

  3. Change from baseline in retinal morphology as measured by SD-OCT [44 weeks]

  4. Change from baseline in MNV lesion area and total MNV leakage area as measured by FA [44 Weeks]

Other Outcome Measures

  1. Number of participants with adverse events [For 44 weeks until the end of the trial]

  2. Serum KHK4951 concentration [44 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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

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 Blue Ocean Clinical Research West Clearwater Florida United States 33761
5 Eye Associates of Pinellas Pinellas Park Florida United States 33782
6 Retina Vitreous Associates of Florida - Saint Petersburg Saint Petersburg Florida United States 33711
7 Vision Research Center Eye Associates of New Mexico Albuquerque New Mexico United States 87109
8 Retina Vitreous Surgeons of Central NY, PC Liverpool New York United States 13088
9 Ophthalmic Consultants of Long Island Oceanside New York United States 11572
10 EyeHealth Northwest Portland Oregon United States 97225
11 Eye Care Specialists Kingston Pennsylvania United States 18704
12 Retina Consultants of Texas Bellaire Texas United States 77401
13 Retinal Consultants of Texas- San Antonio (RCA Network site) San Antonio Texas United States 78240
14 Marsden Eye Specialists Parramatta New South Wales Australia
15 Strathfield Retina Clinic Strathfield New South Wales Australia
16 Sydney Eye Hospital Sydney New South Wales Australia
17 MIYAKE Eye Hospital Nagoya-shi Aiti-ken Japan
18 Hayashi Eye Hospital Fukuoka-shi Fukuoka-ken Japan
19 Minamitohoku Eye Clinic Koriyama-shi Fukushima-ken Japan
20 Kozawa Eye Hospital and Diabetes Center Mito-shi Ibaraki-ken Japan
21 Nihon University Hospital Chiyoda-ku Tokyo-to Japan
22 Tokyo Medical Center Meguro-ku Tokyo-to Japan
23 Yeungnam University Hospital Daegu Daegu Gwang'yeogsi Korea, Republic of
24 Seoul National University Bundang Hospital Seongnam Gyeonggido Korea, Republic of
25 Kim Eye Hospital Seoul Seoul Teugbyeolsi Korea, Republic of
26 Kyung Hee University Hospital Seoul Seoul Teugbyeolsi Korea, Republic of
27 Seoul National University Hospital Seoul Seoul Teugbyeolsi Korea, Republic of
28 The Catholic University of Korea, Seoul St. Mary's 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:
NCT06116890
Other Study ID Numbers:
  • 4951-002
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:
No
Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Aflibercept

Study Results

No Results Posted as of Nov 3, 2023