NL-OMON50742已完成3 期
A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema - CRTH258B2301 (KESTREL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients must give written informed consent before any study related
- •assessments are performed
- •- Patients *18 years of age at baseline
- •- Patients with type 1 or type 2 diabetes mellitus and HbA1c of *10% at
- •- Medication for the management of diabetes must have been stable within 3
- •months prior to randomization and is expected to remain stable during the
- •course of the study
- •- Visual impairment due to DME with:
- •*BCVA score between 78 and 23 letters, inclusive, using Early Treatment
- •Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at a testing
- •distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320), at
- •screening and baseline
- •*DME involving the center of the macula, with central subfield retinal
- •thickness (measured from RPE to ILM inclusively) of *320 *m on SDOCT at
- •screening If both eyes are eligible, the eye with the worse visual acuity will
- •be selected for study eye. However, the investigator may select the eye
- •with better visual acuity, based on medical reasons or local ethical
- •requirements.
排除标准
- •- Previous treatment with any anti-VEGF drugs or investigational drugs in the
- •- Active proliferative diabetic retinopathy in the study eye as per the
- •investigator
- •- Concomitant conditions or ocular disorders in the study eye at screening or
- •baseline which could, in the opinion of the investigator, interfere with study
- •- Any active intraocular or periocular infection or active intraocular
- •inflammation in study eye at screening or baseline
- •- Structural damage of the fovea in the study eye at screening likely to
- •preclude improvement in visual acuity following the resolution of macular edema.
- •- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP)>
- •25 mmHg on medication or according to investigator*s judgment, at screening or
- •- Neovascularization of the iris in the study eye at screening or baseline
- •- Evidence of vitreomacular traction in the study eye at screening or baseline
- •which, in the opinion of the investigator, affect visual acuity
研究者
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