Effect of oral hydroxychloroquine on the macular thickness in patients of non-proliferative diabetic retinopathy with clinically significant macular edema.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in macular thickness.
研究概览
简要总结
PRIMARY PURPOSE
Diabetic retinopathy (DR) is a microvascular complication of diabetes mellitus (DM) that causes vision-threatening damage to the retina, resulting in visual impairment and blindness in the working-age population. Diabetic macular edema (DME) is the most common cause of moderate vision loss in DR. Currently, intravitreal injections of anti-VEGFs are considered the first-line therapy for DME. There is a requirement for multiple injections in an operation theatre setup, which disrupts the professional work, apart from causing a financial burden on the patient.
HCQ has been approved for the management of type 2 DM by the Drug Controller General of India (DCGI) at a dose of 400 mg/day as an adjunct to diet and exercise to improve glycemic control in patients on a combination of metformin and sulfonylureas. The drug was also endorsed by the Research Society for the Study of Diabetes in India (RSSDI) clinical practice recommendations as a third-line drug for managing type 2 DM. It has been proposed that due to its additional anti-inflammatory effect, oral HCQ may prove to be beneficial in DME. However, contradicting reports show no beneficial effect of HCQ on DR. These studies have been retrospective observational types. This study aims to prospectively investigate any beneficial or deleterious effect of HCQ on the DR.
STUDY HYPOTHESIS
HCQ has a beneficial effect on the macular thickness in patients with type 2 DM and DME.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Type 2 diabetes mellitus 2.Moderate to very severe non-proliferative diabetic retinopathy with clinically significant macular edema 3.HbA1C: 7.0-8.5% 4.Hb: more than or equal to 9g/dl 5.On oral antidiabetic drug.
排除标准
- •1.Patients on pioglitazone 2.Uncontrolled hypertension 3.Chronic kidney disease stage 3 and above 4.Cardiac diseases 5.Deranged liver function 6.Patients on tamoxifen citrate 7.Patients with deranged lipid profile (serum triglyceride more than 400mg/dl) 8.Significant media opacity that does not allow adequate fundus evaluation.
- •9.Patients with proliferative diabetic retinopathy 10.Patients requiring antivascular endothelial growth factor injection or have received the same within the last 3 months.
- •11.Patients on insulin 12.Pathological myopia 13.Ocular trauma 14.Any other coexisting retinochoroidal disease or history of vitreoretinal surgery.
结局指标
主要结局
Change in macular thickness.
时间窗: 3 months
次要结局
- Change in macular thickness(6 months)
- Change in best-corrected visual acuity(3 months, 6 months)
- Progression of the grade of DR.(3 months, 6 months)
- Retinal toxicity secondary to hydroxychloroquine (HCQ).(6 months)
研究者
Dr Bruttendu Moharana
All India Institute of Medical Sciences, Bhubaneswar