TCTR20180831001招募中未知
A randomized, multi-centered study of ziv-aflibercept versus bevazicumab on visual outcomes in patients with wet Aged-related macular degeneration
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 450
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
- 60 Years 至 0 N/A (No limit)（—）
- 性别
- All
入选标准
- •1.Age related macular degeneration with serosanguinous maculopathy without prior treatment
- •2.BCVA is between 78 and 24 which is equivalent to 20/32 to 20/320 in Snellen chart
- •3.Choroidal neovascularization and its complication at macular area
- •4.less than 50 percent of fibrosis in total lesion
- •5.no contraindication of intraocular Ziv-aflibercept and bevazicumab administration
排除标准
- •1.Inability to comply with study or follow-up procedures.
- •2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
- •3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include:
- •-Total abstinence (when this is in line with the preferred and usual lifestyle of the
- •subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- •-Female sterilization (have had surgical bilateral oophorectomy with or without
- •hysterectomy) or tubal ligation at least six weeks before taking study treatment. In
- •case of oophorectomy alone, only when the reproductive status of the woman has
- •been confirmed by follow up hormone level assessment
- •-Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient
- •-Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
- •cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository
- •-Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
- •-Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- •In case of use of oral contraception women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.
- •Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- •4. Any type of systemic disease or its treatment, including any medical condition (controlled or uncontrolled) that over the duration of the study could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
- •5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
- •6. Stroke or myocardial infarction within the last 3 months prior to Screening
- •7. Patient with history of porphyria
- •8. Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg while sitting at Screening or Baseline
- •9. Known hypersensitivity to:
- •- Any of the study drugs (ranibizumab or verteporfin) or any component of their
- •formulations or to drugs of similar chemical classes
- •- Fluorescein or indocyanine green
- •10. Use of other investigational drugs within 30 d
研究者
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