A real-world, prospective, multi-center, open-label, phase IV clinical study to evaluate the safety and effectiveness of intravitreal injections (IVI) of brolucizumab in patients with neovascular age-related macular degeneration (nAMD)

ovartis Healthcare Private Limited0 个研究点目标入组 105 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•Female or male, treatment naïve patient with =50 years of age, with neovascular age-related macular degeneration (nAMD).
•Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study.
•Note: In case where both eyes are affected, data of only one eye [‘study eye’] will be recorded. selection of the eye to be considered for the purpose of the study [referred to as ‘study eye’] will be as per the Investigator’s discretion.

•Patient having other eye diseases that could compromise the visual acuity (VA).
•Patient with existing or suspected ocular or periocular infection in the study eye.
•Patient with an existing intraocular inflammation (IOI).
•Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator’s judgment.
•Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study.
•Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.

发起方

ovartis Healthcare Private Limited