Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration

Launched by KYOWA KIRIN CO., LTD. · Oct 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new eye drop medication called KHK4951 to see how effective and safe it is for people with neovascular age-related macular degeneration (nAMD). This condition can lead to vision loss due to abnormal blood vessel growth in the eye. The trial is currently looking for participants aged 18 and older who have specific types of active disease affecting their vision. To join, individuals must be able to provide written consent and meet certain health criteria, such as having a specific level of vision impairment and certain measurements related to their eye condition.

Participants in the trial can expect regular visits for assessments and treatment with KHK4951 eye drops. It’s important to note that some people may not qualify for the study due to specific health issues, such as a history of serious eye problems or certain previous treatments for AMD. Overall, this study aims to offer insights into a potential new treatment option for those affected by this challenging eye condition.

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ALL

Eligibility criteria

• 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
• 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