THE EFFECT OF COMBINATION THERAPY WITH INTRAVITREAL ANTI- VEGF AND TOPICAL DORZOLAMIDE TIMOLOL EYE DROPS ON DIABETIC MACULAR OEDEMA IN COMPARISON TO STANDALONE INTRAVITREAL ANTI-VEGF
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the anatomical and functional outcome with intravitreal bevacizumab(IVB) and topical timolol-dorzalamide versus intravitreal bevacizumab alone in terms of central foveal thickness
研究概览
简要总结
Background and Rationale:
Diabetic Macular Edema (DME) is a leading cause of visual morbidity. Intravitreal anti-VEGF agents are the mainstay of treatment. Recent evidence suggests that aqueous suppressants like dorzolamide-timolol may prolong intravitreal drug action by reducing aqueous outflow and attenuate post injection rise in IOP, thereby potentially improving the efficacy. This study aims to evaluate whether adjuvant dorzolamide-timolol enhances the therapeutic effect of intravitreal bevacizumab in DME.
Study Design:
Hospital based RCT, single centre and parallel group
Study Population:
Patients>40yrs with centre involving DME and Central Foveal Thickness >300microns
Exclusion: Extrafoveal DME, Vitreous Haemorrage, tractional bands, glaucoma and any person on anti-glaucoma therapy, CAD,CKD, sulpha allergy
Intervention:
GROUP-A (IVB+TD) : Monthly intravitreal Bevacizumab (IVB) injection + dorzolamide - timolol eye drops twice a daily
GROUP-B (IVB only) : Monthly Intravitreal Bevacizumab (IVB) injection + articifical tear drops
Sample Size:
80 subjects (40 per arm), with 80% power and 5% alpha error
Outcome Measure:
Primary: Change in CFT
Secondary: Changes in BCVA and IOP variations
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 40yrs Patients with centre involving diabetic macular edema with central foveal thickness of more than 300 microns.
排除标准
- 未提供
结局指标
主要结局
To compare the anatomical and functional outcome with intravitreal bevacizumab(IVB) and topical timolol-dorzalamide versus intravitreal bevacizumab alone in terms of central foveal thickness
时间窗: Baseline - 1st Visit | After 4 weeks - 1st Follow Up | After 8 weeks - 2nd Follow Up | After 12 weeks - 3rd Follow Up
次要结局
- To check the variation in IOP of the patient(Baseline - 1st Visit)
研究者
Neel Nathmal Kavediya
Madras Medical College RIO-GOH, Chennai