Comparison of 0.1% Nepafenac and 0.3% Nepafenac eye drops in reduction of macular thickness and improvement of visaul acuity in patient with diabetic macular edema - a randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- 2.No. of eyes with at least 5 letters decrease or increase from baseline in ETDRS chart.
研究概览
简要总结
IN THIS STUDY WE WILL COMPARE NEPAFENAC 0.1% EYE DROPS AND NEPAFENAC 0.3% EYE DROPS IN PATIENTS WITH DIABETIC MACULAR EDEMA. PATIENTS MEETING THE INCLUSION CRITERIA WILL BE RECRUITED IN THE STUDY WITH CONSENT AND WILL BE RANDOMIZED IN TO 2 GROUP. GROUP 1 WILL RECEIVE NEPAFENAC 0.1 % EYE DROPS, TO BE INSTILLED IN TO AFFECTED EYE THREE TIMES A DAYS FOR SIX MONTHS. GROUP 2 WILL RECEIVE NEPAFENAC 0.3% EYE DROPS, TO BE INSTILLED IN TO AFFECTED EYE ONCE DAILY FOR SIX MONTHS. BASELINE MACULAR THICKNESS WILL BE COMPARED FOR ALL THE PATIENT ON RECRUITMENT OF THE PATIENT IN THE SUTDY AND PATIENT WILL BE FOLLOWED FOR 6 MONTHS ON 1ST, 4TH AND SIXTH MONTH VISIT. IN ALL THE VISITS MACULAR THICKENESS WILL BE RECORED AND WILL BE COMPARED WITH BASE LINE MACULAR THICKENESS. FINALLY TWO GROUPS WILL COMPARED IN TERMS OF REDUCTION OF MACULAR THICKENESS. MACULAR THICKNESS WILL BE RECORDED BY INVESTIGATION KNOW AS OPTICAL COHERENCE TOMOGRAPHY. BASELINE VISUAL ACUTIY WILL ASLO BE RECORDED USING EDTRS CHART AND WILL BE COMPARED IN SUBSEQUENT VISITS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient age > 18 years 2.DME- macular thickness > 250 microns 3.BCVA – 6/12 or better, 20/40 letters of ETDRS chart.
排除标准
- •1.Any ocular surgical procedure in past 3 months 2.Any laser/ intra-vitreal injection procedures in past 3 months.
- •3.Any patient who had undergone cataract surgery in the study eye in past 1 year.
- •4.Vision 6/18 or poor or 20/60 on ETDRS chart.
- •5.Uncontrolled sugar
- •Any previous history of allergy to nepafenac.
结局指标
主要结局
2.No. of eyes with at least 5 letters decrease or increase from baseline in ETDRS chart.
时间窗: 1st, 4th, 6th months
1.Reduction of Central sub-field (CSF) macu-lar thickness.
时间窗: 1st, 4th, 6th months
次要结局
- 1.Change in OCT central sub-foveal choroidal thickness from baseline.(1st, 4th, 6th months)