A Randomised Controlled Trial Comparing Efficacy of Single Versus Multiple Intravitreal Anti-VEGF Injections to Prevent Diabetic Retinopathy Progression in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Change from basseline in diabetic retinopathy severity at 6 months
研究概览
简要总结
Objective of this randomised controlled trial is to compare the efficacy of a single per operative anti VEGF injection with repeated postoperative anti VEGF injections in the prevention of diabetic retinopathy progression after cataract surgery.
This Randomised Controlled Trial (RCT) will be conducted at Sahiwal Teaching Hospital and University College of Medicine & Dentistry Lahore. Duration of study will be from January 2026 to September 2026. This study will be single blind and parallel group research.
The study will include diabetic patients of both sexes ≥ 40 years of age presenting with non-proliferative diabetic retinopathy and cataract.
Exclusion criteria include proliferative diabetic retinopathy, center-involving diabetic macular oedema (DME), poor glycemic control (HbA1c >9%), glaucoma, uveitis, prior ocular surgery or laser, and recent systemic thromboembolic events.
Subjects will be randomly divided into two groups, each containing 83 subjects. Standard phacoemulsification with intraocular lens implantation will be performed in all participants.
A single intra vitreal Aflibercept injection ( 2mg/0.05 ml ), will be given to group 1 participants. While, group 2 participants will receive an intra operative injection plus two additional injections at 1 month and 2 months postoperatively.
For all participants, follow up will be performed at 1 week, 1 month, 2 month, 3 month and 6 month.
Primary Outcome include progression of diabetic retinopathy (DR) severity (≥1 stage according to the guidelines of the international clinical diabetic retinopathy disease severity scale ICDR) or onset/progression of DME.
Secondary Outcomes include changes in best corrected visual acuity, changes in central macular thickness (CMT), and need for rescue treatment.
SPSS version 26 will be utilised to analyse the data. P ≤ 0.05 will be taken as statistically significant. Qualitative variable like diabetic retinopathy grading and diabetic macular oedema status will be analysed by utilising Pearson's chi-square test. Quantitative variables like central macular thickness will be analysed by employing t-test.
详细描述
Title A randomized controlled trial comparing efficacy of single versus multiple intravitreal anti VEGF injections to prevent diabetic retinopathy progression in patients undergoing cataract surgery
Brief Title Comparing single versus multiple anti VEGF injections in diabetic patients undergoing cataract surgery.
Topic of interest: Role of anti VEGF injections in preventing progression of diabetic retinopathy in patients undergoing cataract surgery.
Research gap: A comparison of different dosing protocols in preventing progression of diabetic retinopathy in patients undergoing cataract surgery is not available.
Research question Among patients with diabetic retinopathy undergoing cataract surgery, does a single intravitreal anti-VEGF injection or a multiple-injection protocol more effectively prevent disease progression? Introduction Diabetic retinopathy is an emerging leading cause of defective vision worldwide . Systemic risk factors are important in causation of diabetes related visual morbidity . Cataract surgery is the most commonly performed elective surgery world-wide . Cataract surgery leads to increase in inflammatory mediators including vascular endothelial growth factor (VEGF) that can lead to progression of diabetic retinopathy . Before planning cataract surgery, diabetic control is utmost important . Despite good glycaemic control cataract surgery can result in progression of diabetic retinopathy and leading to unsatisfactory visual outcomes despite good cataract surgery . Different measures are taken to suppress inflammation associated with cataract surgery. Phacoemulsification in contrast to extracapsular cataract surgery leads to less inflammation and early recovery. Use of perioperative and postoperative steroids and nonsteroidal anti-inflammatory drugs significantly result in less post cataract surgery inflammation and hence less chances of progression of diabetic retinopathy . Despite all these measures diabetic retinopathy does show progression after cataract surgery . It has been shown that per operative use of anti VEGF injection prevents the progression of diabetic retinopathy. Anti-VEGF agents stop the action of VEGF by binding to the VEGF chemical, thereby preventing it from attaching to its receptors . But action of anti VEGF injections is short lived. It has been shown that post operative inflammation can persist many weeks after cataract surgery especially in diabetic patients. So there should be a need of repeated anti VEGF injection to completely mitigate the effects of cataract surgery induced inflammation in the progression of diabetic retinopathy . Currently there is no consensus on dosing protocol of anti-VEGF agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic patients of both sexes ≥ 40 years of age presenting with non-proliferative diabetic retinopathy and cataract
排除标准
- •presence of proliferative diabetic retinopathy (PDR), diabetic macular oedema involving foveal centre, history of intraocular surgery or laser photocoagulation or prior anti-VEGF injection therapy in the study eye within past six months, history of intraocular inflammation (uveitis), glaucoma, mature cataract preventing satisfactory fundus examination preoperatively, poor glycaemic control (HbA1c>9%), pregnant and lactating women, known allergy to aflibercept (anti-VEGF used) and systemic thromboembolic events (stroke, myocardial infarction) within the last three months.
研究组 & 干预措施
Single injection Group
Intravitreal Aflibercept 2mg/0.05ml injection will be given by standard technique at the end of Phacoemulsification with Intraocular lens implantation
干预措施: Aflibercept (Eylea) (Drug)
Multiple Injection Group
This group will receive Aflibercept intravitreal injection 2mg/0.05ml by standard technique at the end of the phacoemulsification with intraocular lens implantation and then at 1st, and 2nd months postoperatively.
干预措施: Aflibercept (Eylea) (Drug)
结局指标
主要结局
Change from basseline in diabetic retinopathy severity at 6 months
时间窗: Within six months after phacoemulsification with intraocular lens implantation
Change in diabetic retinopathy severity ≥1 stage increase in international clinical diabetic retinopathy disease severity scale (ICDR) or onset or progression of diabetic macular oedema
次要结局
未报告次要终点
研究者
Ahmad Zeeshan Jamil
Professor and Head, Department of Ophthalmology
University of Health Sciences Lahore