Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular… (NCT06116890) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration
United States180 participantsStarted 2024-01-31
Plain-language summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) corticosteroi…
What they're measuring
1
Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baseline
Timeframe: For 44 weeks until the end of the trial