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

Korábbi kezelés

• 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

Más betegség

• Subretinal hemorrhage, fibrosis, or atrophy of > 50% of the total lesion area and/or that involves the fovea 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
• Any current or history of endophthalmitis in either eye
• History of idiopathic or autoimmune-associated uveitis in either eye

Egyéb

• Uncontrolled glaucoma in the study eye
• Aphakia or pseudophakia with AC-IOL in the study eye
• Active intraocular inflammation in the study eye
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

• 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