CTRI/2018/09/015622已完成3 期
A Two-Year, Two-Arm, Randomized, Double-Masked,Multicenter, Phase III Study Assessing the Efficacy andSafety of Brolucizumab versus Aflibercept in Adult Patientswith Visual Impairment due to Diabetic Macular Edema - KITE
ovartis Healthcare Pvt Ltd0 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
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
入选标准
- •1.Patients must give written informed consent before any study related
- •assessments are performed
- •2. Patients ââ?°Â¥18 years of age at baseline
- •3. Patients with type 1 or type 2 diabetes mellitus and HbA1c of ââ?°Â¤10% at
- •4. 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
- •5. 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
- •Ã¯â??· DME involving the center of the macula, with central subfield retinal
- •thickness (measured from RPE to ILM inclusively) of ââ?°Â¥340 Ã?¼m on SD-OCT 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 study eye
- •2. Active proliferative diabetic retinopathy in the study eye as per the
- •investigator
- •3. Concomitant conditions or ocular disorders in the study eye at
- •screening or baseline which could, in the opinion of the investigator,
- •prevent response to study treatment or may confound interpretation of
- •study results, compromise visual acuity or require medical or surgical
- •intervention during the first 12-month study period (e.g., cataract,
- •vitreous hemorrhage, retinal vascular occlusion, retinal detachment,
- •macular hole, or choroidal neovascularization of any cause)
- •4. Any active intraocular or periocular infection or active intraocular
- •inflammation (e.g., infectious conjunctivitis, keratitis, scleritis,
- •endophthalmitis, infectious blepharitis, uveitis) in study eye at
- •screening or baseline
- •5. Structural damage of the fovea in the study eye at screening likely to
- •preclude improvement in visual acuity following the resolution of
- •macular edema, including atrophy of the retinal pigment epithelium,
- •subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or
- •organized hard exudate plaques
- •6. Uncontrolled glaucoma in the study eye defined as intraocular pressure
- •(IOP) > 25 mmHg on medication or according to investigatorââ?¬•s
- •judgment, at screening or baseline
- •7. Neovascularization of the iris in the study eye at screening or baseline
- •8. 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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