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.
diabetic patients of both sexes ≥ 40 years of age presenting with non-proliferative diabetic retinopathy and cataract
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.
Parallel
Aflibercept (Eylea)
DrugSingle injection group will receive aflibercept intravitreal injection 2mg/0.05ml by the standard technique at the end of phacoemulsification with intraocular lens implantation. Multiple injection group will receive aflibercept intravitreal injection 2mg/0.05ml by standard technique at the end of phacoemulsification with intraocular lens implantation and then at 1st, and 2ndmonths postoperatively.
Change from basseline in diabetic retinopathy severity at 6 months
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
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Ahmad Zeeshan Jamil
Lead sponsor
University of Health Sciences Lahore
Sponsor institution
Sahiwal medical college sahiwal
Collaborator
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