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临床试验/NCT05083689
NCT05083689Unknown2 期

Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年10月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
62
试验地点
1
主要终点
Central macular thickness

研究概览

简要总结

This study is a double-blind randomized clinical trial in Diabetic patients (type 2) over 18 years of age who have diabetic macular edema with involvement of the central 1 millimeter (central macular thickness is more than 300 μm) and BCVA 20/30 or less who visit the retina clinic of Labbafinejad Hospital Are studied. (In patients with bilateral macular edema, only one eye is included in the study.) Complete ocular examinations (including best corrected visual acuity - anterior segment - intraocular pressure - dilated pupil funduscopy with severity of diabetic retinopathy), optical coherence tomography (OCT), EDI-OCT( Enhanced Depth Imaging Optical Coherence Tomography ) - as well as Optical coherence tomography angiography (OCTA ) are performed for all patients at baseline. Blood tests are also taken from patients for fasting blood sugar and HbA1C. Patients are then randomly divided into two groups. The first group is treated with injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of Timolol twice a day and Dorzolamide twice a day. For the second group (control group), 3 injections of 1.25 mg of intravitreal bevacizumab monthly with artificial tears (twice a day as a placebo) are prescribed. Patients in both groups are visited 1 month after the third basic intravitreal bevacizumab (IVB) injection and complete ophthalmology examinations are performed and central thickness of macula is recorded based on the patient's OCT as well as the need for IVB re-injection. EDI (Enhanced Depth Imaging)-OCT and OCTA are performed again for all patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Diabetic Melitus type 2
  • Patients with center-involving diabetic macular edema (central macular edema > 300 micrometer)
  • Patients have diabetic retinopathy at the stage of nonproliferative diabetic retinopathy (NPDR) or early PDR (proliferative diabetic retinopathy) or regressed PDR
  • In patients with bilateral macular edema, only one eye is included in the study.

排除标准

  • uncomplicated cataract surgery
  • history of cataract surgery during last 4 months
  • history of Panretinal Photocoagulation (PRP) during last 4 months
  • any retinochoroidal disease except Diabetic retinopathy
  • optic disc pathology
  • patient with high-risk PDR or advanced PDR
  • one-eye patients
  • patient with glaucoma or uveitis
  • pregnant or lactating patients
  • patients whom topical Timolol or Dorzolamide are prohibited for any reason

研究组 & 干预措施

Injections of 1.25 mg of intravitreal bevacizumab with topical drops of Timolol and Dorzolamide

Active Comparator

31 cases in intervention group receive injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of Timolol twice a day and Dorzolamide twice a day

干预措施: Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide (Drug)

Injections of 1.25 mg of intravitreal bevacizumab with artificial tears

Placebo Comparator

31 cases in control group receive intravitreal injection of 1.25 mg bevacizumab monthly for 3 months (months 0, 1 and 2) plus artificial tears (twice a day as a placebo)

干预措施: Injections of 1.25 mg of intravitreal bevacizumab with artificial tears (Drug)

结局指标

主要结局

Central macular thickness

时间窗: 1 month

Measured by EDI-OCT

次要结局

  • Best corrected visual acuity (BCVA)(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Rabbani Khah

Head of ophthalmic research center

Shahid Beheshti University of Medical Sciences

研究点 (1)

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