JPRN-jRCTs061180035已完成4 期
Ranibizumab Exploratory Study on the Evaluation of the local laser combination therapy to non-reactive group to the diabetic macular edema patients - The local laser combination therapy to non-reactive group of ranibizumab to diabetic macular edema
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
A comparison of the change in visual acuity between ranibizumab plus local laser and ranibizumab monotherapy for non-responders to ranibizumab in DME patients showed no significant difference between the two groups. There was no significant difference in the number of doses of ranibizumab administered between the two groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)patients who have diabetes, and have developed in at
- •least one eye diabetic macular edema Patients
- •2)does not recognize the acute myocardial infarction and
- •cerebral infarction within the onset 3 months Patient age is greater than or equal to 20 years of age at the time of
- •3)obtaining informed consent
- •4)gender unquestioned
- •5)After having received a sufficient explanation Upon participation in the present study, patients on the full understanding, the document agreed by the free will of the patient himself was obtained
- •6)hospitalization, outpatient unquestioned
排除标准
- •1)Patients with a treatment history of anti VEGF drugs
- •2)Patients with infection or infection suspictions in the
- •eye or around the eye
- •3)Patients with severe inflammation in the eye
- •4)DME disease duration is more than 12 months
- •5)Patients who underwent direct photocoagulation to 3
- •months in DME within 1000um from the fovea
- •6)Patients who underwent triamcinolone acetonide subtenon
- •injection or triamcinolone acetonide intravitreal
- •injectionwithin 3 months
- •7)Patients who underwent PRP within 6 months
- •8)HbA1c is over 10.0%
- •9)Poor control of hypertension
- •10)Eye surgery within 6 months
- •11)ranibizumab or to the components of other anti-VEGF
- •drugs, those with a history of hypersensitivity
- •12)Pregnancy, in nursing
- •13)Other,patient research responsibility who is determined
- •to be unsuitable as research subjects
研究者
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