Status:
ACTIVE_NOT_RECRUITING
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Neovascular Age-Related Macular Degeneration (nAMD)
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06116890
Start Date
January 31 2024
End Date
September 30 2026
Last Update
October 30 2025
Active Locations (84)
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1
Barnet Dulaney Perkins Eye Center - Phoenix
Mesa, Arizona, United States, 85206
2
Retina Associates Southwest, P.C.
Tucson, Arizona, United States, 85710
3
Win Retina
Arcadia, California, United States, 91006
4
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211