The OZPRIME study- Assessing efficacy and response variance after dexamethasone implant priming with two different types of AntiVEGF agents- A randomized control trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of OZPRIME strategy in management of DME over a 24-week treatment period and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2mg)
研究概览
简要总结
Diabetic macular oedema is one of the leading cause of vision loss and blindness in patients with diabetes mellitus. Though anti VEGF agents have been hugely popular and the current treatment of choice for the treatment of centre involving diabetic macular oedema. The role of steroids particularly Ozurdex has been increasing. Though Anti VEGF studies have demonstrated improved visual and anatomical outcomes with well tolerated safety profiles, the major disadvantage has been frequent injection and prolonged treatment care. One strategy to offset his problem could be the addition of intravitreal steroids like Ozurdex along with anti VEGF therapy using a fixed strategy.
Our study aims at comparing outcomes after a novel strategy called Ozprime strategy wherein ozurdex implantation in first month followed by antiVEGF injections at fourth and fifth month is compared with monthly antiVEGF injections for five months using Ranibizumab biosimilar and aflibercept over 24 weeks period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female Patients at least 18 years of age attending the outpatient clinic with NPDR and Diabetic macular edema in at least one eye during the study period will be randomly included after taking an informed consent.
- •Snellen Visual acuity (BCVA greater than 34 and lesser than 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters).
排除标准
- •Glycated hemoglobin (HbA1c) more than 12 at baseline.
- •Intraocular pressure (IOP) more than 22 mmHg at screening or on day 1
- •A diagnosis of glaucoma or patients with glaucoma suspects
- •A history of laser treatment within 3 months prior to screening
- •Use of anti-VEGF treatment within 3 months prior to screening
- •Patients who are not willing to participate in this study.
结局指标
主要结局
To evaluate efficacy of OZPRIME strategy in management of DME over a 24-week treatment period and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2mg)
时间窗: 24 weeks
次要结局
- 2) To evaluate the change in retinal thickness in Optical Coherence Tomography (OCT) after 24 weeks following OZPRIME strategy and compare with antiVEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2 mg).
- 3) To evaluate the number of injections required in eyes undergoing OZPRIME strategy and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg and Aflibercept 2mg).
- 1) To evaluate the mean change of Best corrected Visual acuity following OZPRIME strategy and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2 mg).(24 weeks)
研究者
Dr Unnikrishnan Nair
Chaithanya Eye Hospital and research institute