Comparison of effect of combination therapy with intravitreal injection of Ranibizumab and photocoagulation versus Pan Retinal Photocoagulation in Severe Non Proliferative Diabetic retinopathy and Proliferative Diabetic Retinopathy with or without Macular edema
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the effects of ranibizumab on Best Corrected Visual Acuity (BCVA) and Central Macular Thickness (CMT) every monthly in both groups
研究概览
简要总结
This prospective interventional study will be conducted on 25 patients in each group fulfilling the inclusion and exclusion criteria in the department of ophthalmology R L Jalappa Hospital and Research , Kolar after obtaining Ethical clearance from Institutional ethical committee of Sri Devaraj Urs Academy of Higher Education and Research and written informed consent from the participants. The primary outcome of this study to measure Best Corrected Visual Acuity ( BCVA) and Central Macular Thickness ( CMT) every monthly in both groups to evaluate the effects of ranibizumab. The Secondary Outcome is regression of Neovascularization from base line to month 12. It will be recorded in both groups at 3. 6, 9, and 12 months follow up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with Type-1 and Type-2 diabetes mellitus between 18 years to 65 years of age of both genders
- •Patients with severe NPDR or proliferative DR in both eyes with or without clinically significant macular edema (CSME) established by optical coherence tomography of Central Macular Thickness greater than 300 microns were included in the study
- •Visual impairment due to Diabetic Macular Edema in at least one eye
- •HbA1c Less than 10.0
- •High risk Proliferative Diabetic Retinopathy.
排除标准
- •History of prior laser treatment or vitrectomy in the study eye
- •Major surgery within the prior 6 months or planned within the next 28 days
- •Uncontrolled hypertension
- •Those patients with mature cataract or media opacities due to poor quality Optical Coherence Tomography images were all excluded from the study
- •Previous use of intravitreal corticosteroid application in phakic study eyes or chronic treatment with topical ocular or systemic corticosteroids
- •Those with previous treatment with anti angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.,) within three months of the day 0 (first day of treatment) visit.
- •Those with Proliferative Diabetic Retinopathy (PDR) in the study eye, iris neovascularization, vitreous hemorrhage, traction retinal detachment, or pre retinal fibrosis involving the macula in the study eye
- •Uncontrolled glaucoma and ocular trauma
- •Any condition that could affect follow up or documentation (including pre retinal or vitreous hemorrhage)
- •Changes in the vitreous-retinal interface (epiretinal membrane, macular hole and vitreoretinal traction syndrome)
- •Prior Thromboembolic events including myocardial infarction, stroke and deep vein thrombosis 12.
结局指标
主要结局
To evaluate the effects of ranibizumab on Best Corrected Visual Acuity (BCVA) and Central Macular Thickness (CMT) every monthly in both groups
时间窗: month 3 to 11
次要结局
- Regression of Neovascularization: total Neovascularization Disc + Neovascularization Elsewhere (NVD+ NVE)(Month 1 to 12)
研究者
Dr Narendran BS
Sri Devaraj Urs Academy of higher education and research