Prospective, multi-center, randomized, double-blind, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety ofR-TPR-024 / LucentisÂ® in patients with neovascular (wet) age-related macular degeneration

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 159 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male or female patients of age >= 50 years.
•2.Active primary or recurrent subfoveal lesions with classic or occult choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
•3.Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye.

•1.Treatment with verteporfin photodynamic therapy in the study eye within 6 months or in the nonstudy eye within 1 week prior to randomization.
•2.Previous external-beam radiation therapy, transpupillary thermotherapy or subfoveal focal laser photocoagulation in the study eye.
•3.Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month prior to randomization.
•4.CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
•5.Patients with controlled or uncontrolled diabetes mellitus.

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