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临床试验/NCT07690800
NCT07690800已完成4 期

Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage: A Prospective Interventional Cohort Study

Benha University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in Best-Corrected Visual Acuity (BCVA)

研究概览

简要总结

This prospective interventional cohort study evaluates the outcomes of intravitreal ranibizumab injection in patients with diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy. The study aims to assess the effectiveness of ranibizumab in improving visual acuity, promoting vitreous hemorrhage clearance, reducing the need for pars plana vitrectomy, and evaluating treatment-related safety.

Eligible adult patients with diabetic vitreous hemorrhage will receive intravitreal ranibizumab according to the study protocol and will be followed for 3 to 6 months with serial ophthalmic examinations. Outcome measures include changes in best-corrected visual acuity, vitreous hemorrhage severity, treatment-related complications, and the proportion of patients requiring vitrectomy. Panretinal photocoagulation may be performed when adequate retinal visualization is achieved.

详细描述

Diabetic vitreous hemorrhage is a common vision-threatening complication of proliferative diabetic retinopathy. Hemorrhage into the vitreous cavity results from fragile retinal neovascularization and may cause marked visual impairment while preventing adequate retinal examination and laser treatment. Although pars plana vitrectomy remains the standard treatment for persistent or non-clearing vitreous hemorrhage, intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has emerged as a potential treatment option for selected patients.

Ranibizumab is a recombinant humanized monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), thereby reducing neovascular activity and vascular permeability. Suppression of VEGF may facilitate clearance of vitreous hemorrhage, improve visual acuity, allow subsequent panretinal photocoagulation, and reduce the need for vitrectomy.

This is a single-center prospective interventional cohort study conducted at the Ophthalmology Department of Benha University Hospital. Adult patients with diabetic vitreous hemorrhage who meet the eligibility criteria will receive intravitreal ranibizumab (0.5 mg/0.05 mL) under aseptic conditions. Patients will undergo comprehensive ophthalmic evaluation before treatment, including best-corrected visual acuity assessment, slit-lamp biomicroscopy, intraocular pressure measurement, fundus examination, and ocular imaging as clinically indicated, including optical coherence tomography, fluorescein angiography, or B-scan ultrasonography.

Participants will be followed after one week, one month, and monthly thereafter for 3 to 6 months. Additional ranibizumab injections may be administered after at least one month when clinically indicated. Panretinal photocoagulation may be performed once sufficient fundus visualization is obtained. Pars plana vitrectomy will be performed for worsening vitreous hemorrhage, persistent moderate or severe hemorrhage without adequate improvement, or the development of tractional retinal detachment involving the posterior pole.

The primary objectives are to evaluate improvement in best-corrected visual acuity and clearance of vitreous hemorrhage following intravitreal ranibizumab treatment. Secondary objectives include assessment of treatment-related adverse events and determination of the proportion of patients requiring pars plana vitrectomy during follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Adults aged 20 to 70 years.
  • Type 1 or Type 2 diabetes mellitus.
  • Diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy.
  • Treatment-naïve diabetic vitreous hemorrhage or recurrent/residual vitreous hemorrhage following previous panretinal photocoagulation.
  • Phakic or pseudophakic eyes.
  • Able and willing to provide written informed consent.

排除标准

  • Significant tractional retinal detachment or retinal traction requiring immediate surgery.
  • Previous ocular surgery other than cataract surgery.
  • Previous intravitreal pharmacologic treatment within the preceding 6 months.
  • Any type of glaucoma.
  • Active ocular infection or significant ocular surface disease.
  • No light perception vision.
  • Known hypersensitivity to ranibizumab or any component of the study medication.
  • Refusal or inability to provide informed consent.

结局指标

主要结局

Change in Best-Corrected Visual Acuity (BCVA)

时间窗: Baseline through 6 months

Change in BCVA from baseline to the end of follow-up, measured using Snellen visual acuity and converted to logMAR for statistical analysis.

次要结局

  • Need for Additional Ranibizumab Injections(Baseline through 6 months)

研究者

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

Ehab Mohamed Elsayed Mohamed Saad

Lecturer

Benha University

研究点 (1)

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