Comparing Single Versus Multiple Anti-VEGF Injections in Diabetic Patients Undergoing Cataract Surgery

NCT07301775 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 290/IRB/SLMC/SWL
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetic Retinopathy (DR); Cataract; Diabetic Macular Edema (DME); Phacoemulfisication+IOL Implantation; Intravitreal Injection

Keywords

Vascular endothelial growth factor; Aflibercept; Cataract Extraction; Intravitreal Injection; Phacoemulsification; Diabetic retinopathy; Diabetic macular edema; Intraocular lens implantation

Outcome Measures

Primary Outcomes (1)

• 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

  Within six months after phacoemulsification with intraocular lens implantation

Study Arms (2)

Single injection Group

ACTIVE COMPARATOR

Intravitreal Aflibercept 2mg/0.05ml injection will be given by standard technique at the end of Phacoemulsification with Intraocular lens implantation

Drug: Aflibercept (Eylea)

Multiple Injection Group

EXPERIMENTAL

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.

Drug: Aflibercept (Eylea)

Interventions

Aflibercept (Eylea) DRUG

Single 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.

Multiple Injection Group; Single injection Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetic patients of both sexes ≥ 40 years of age presenting with non-proliferative diabetic retinopathy and cataract

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmad Zeeshan Jamil: lead
• Sahiwal medical college sahiwal: collaborator

Study Sites (2)

University College of Medicine and Dentistry (UCMD)

Lahore, Punjab Province, 54000, Pakistan

Location

Sahiwal Medical College and Sahiwal Teaching Hospital

Sahiwal, Punjab, Pakistan, 57000, Pakistan

Location

Related Publications (14)

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  PMID: 13129861 BACKGROUND

• Pollack A, Dotan S, Oliver M. Progression of diabetic retinopathy after cataract extraction. Br J Ophthalmol. 1991 Sep;75(9):547-51. doi: 10.1136/bjo.75.9.547.

  PMID: 1911658 BACKGROUND

• Chung J, Kim MY, Kim HS, Yoo JS, Lee YC. Effect of cataract surgery on the progression of diabetic retinopathy. J Cataract Refract Surg. 2002 Apr;28(4):626-30. doi: 10.1016/s0886-3350(01)01142-7.

  PMID: 11955902 BACKGROUND

• Starr MR, Mahr MA, Smith WM, Iezzi R, Barkmeier AJ, Bakri SJ. Outcomes of Patients With Active Diabetic Macular Edema at the Time of Cataract Surgery Managed With Intravitreal Anti-Vascular Endothelial Growth Factor Injections. Am J Ophthalmol. 2021 Sep;229:194-199. doi: 10.1016/j.ajo.2021.04.002. Epub 2021 Apr 20.

  PMID: 33852907 BACKGROUND

• Hu W, Ni L, Ying H, Zhang Z, Tu S, Tao Y, Chen L. Efficacy of fluocinolone acetonide implant in diabetic macular edema patients previously treated with dexamethasone implant: A systematic review and meta-analysis. Pak J Med Sci. 2025 Aug;41(8):2388-2398. doi: 10.12669/pjms.41.8.12675.

  PMID: 40980399 BACKGROUND

• Cheema RA, Al-Mubarak MM, Amin YM, Cheema MA. Role of combined cataract surgery and intravitreal bevacizumab injection in preventing progression of diabetic retinopathy: prospective randomized study. J Cataract Refract Surg. 2009 Jan;35(1):18-25. doi: 10.1016/j.jcrs.2008.09.019.

  PMID: 19101420 BACKGROUND

• Haddad JE, Sabbakh NA, Macaron MM, Shaaban H, Bourdakos NE, Shi A, Saad B, Nakanishi H, Than CA, Daoud YJ. NSAIDs and Corticosteroids for the Postoperative Management of Age-Related Cataract Surgery: A Systematic Review and Meta-analysis. Am J Ophthalmol. 2024 Apr;260:1-13. doi: 10.1016/j.ajo.2023.09.027. Epub 2023 Oct 4.

  PMID: 37797866 BACKGROUND

• Kropp M, Golubnitschaja O, Mazurakova A, Koklesova L, Sargheini N, Vo TKS, de Clerck E, Polivka J Jr, Potuznik P, Polivka J, Stetkarova I, Kubatka P, Thumann G. Diabetic retinopathy as the leading cause of blindness and early predictor of cascading complications-risks and mitigation. EPMA J. 2023 Feb 13;14(1):21-42. doi: 10.1007/s13167-023-00314-8. eCollection 2023 Mar.

  PMID: 36866156 BACKGROUND

• Kaur A, Kumar R, Sharma A. Diabetic Retinopathy Leading to Blindness- A Review. Curr Diabetes Rev. 2024;20(9):e240124225997. doi: 10.2174/0115733998274599231109034741.

  PMID: 38275038 BACKGROUND

• Han X, Zhang J, Liu Z, Tan X, Jin G, He M, Luo L, Liu Y. Real-world visual outcomes of cataract surgery based on population-based studies: a systematic review. Br J Ophthalmol. 2023 Aug;107(8):1056-1065. doi: 10.1136/bjophthalmol-2021-320997. Epub 2022 Apr 11.

  PMID: 35410876 BACKGROUND

• Lee SH, Tseng BY, Wu MC, Wang JH, Chiu CJ. Incidence and Progression of Diabetic Retinopathy After Cataract Surgery: A Systematic Review and Meta-Analysis. Am J Ophthalmol. 2025 Jan;269:105-115. doi: 10.1016/j.ajo.2024.08.017. Epub 2024 Aug 22.

  PMID: 39179126 BACKGROUND

• Rachmilevich A, Yanculovich N, Hazan I, Tsumi E, Liberty IF. Glycemic control and macular edema in patients undergoing cataract surgery. Prim Care Diabetes. 2023 Feb;17(1):55-59. doi: 10.1016/j.pcd.2022.12.004. Epub 2023 Jan 2.

  PMID: 36599797 BACKGROUND

• Sruthi R, Saikumar SJ, Gopalakrishnan M. Progression of diabetic retinopathy following uncomplicated phacoemulsification: A prospective study from South India. Oman J Ophthalmol. 2024 Feb 21;17(1):72-77. doi: 10.4103/ojo.ojo_292_22. eCollection 2024 Jan-Apr.

  PMID: 38524349 BACKGROUND

• Wu J, Zhou Y, Zhen F, Wang S, Li Q, Dong S. Management after cataract surgery for patients with diabetic retinopathy: a systematic review and meta-analysis. Int Ophthalmol. 2024 Apr 1;44(1):166. doi: 10.1007/s10792-024-02981-6.

  PMID: 38557801 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy; Cataract

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Lens Diseases

Study Officials

• AHMAD ZEESHAN JAMIL, FCPS, FRCS, FCPS(VRO)

  Sahiwal Medical College and Sahiwal Teaching Hospital Sahiwal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad Zeeshan Jamil, FCPS, FRCS, FCPS(VRO)

CONTACT

+92 333 4853851; ahmadzeeshandr@gmail.com

Muhammad Hannan Jamil, FCPS, FRCS, FCPS(VRO)

CONTACT

+92 333 6113166; hannnan.jamil@ucm.uol.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Head, Department of Ophthalmology

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data (IPD) will be made available beginning 6 months after publication of the primary results and will remain accessible for a period of 2 years following study completion.
• Access Criteria: De-identified individual participant data (IPD) and supporting documents (protocol, SAP, consent template) will be available to qualified researchers affiliated with academic or medical institutions. Access will be granted upon IRB approval and execution of a data-sharing agreement. Data will be shared via secure institutional repository within 6-12 months after publication and remain available for 2 years.

Locations

PA (2)