Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema

COMPLETED

NCT07663370

Sponsor: Benha University

Summary

Diabetic macular edema (DME) is a leading cause of vision loss in patients with diabetes. Anti-VEGF agents are widely used to improve vision and reduce retinal swelling. However, treatment cost remains a major barrier in many healthcare systems. This study evaluates the real-world effectiveness and safety of a ranibizumab biosimilar in patients with DME. Medical records of adult patients treated at a tertiary ophthalmology center will be reviewed. Changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) will be analyzed from baseline to final follow-up, along with treatment burden and safety outcomes. The findings aim to provide evidence on visual and anatomical outcomes following biosimilar anti-VEGF therapy in routine clinical practice.

Official title: Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema: A Retrospective Observational Cohort Study

Key Details

Gender

All

Age Range

Any - 80 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2022-01-01

Completion Date

2026-04-15

Last Updated

2026-06-23

Healthy Volunteers

No

Conditions

Anti-VEGF Treatment Ranibizumab Biosimilar

Interventions

DRUG

Ranibizumab biosimilar

Intravitreal ranibizumab biosimilar administered as part of routine clinical care for the treatment of center-involving diabetic macular edema. Patients included in this retrospective cohort received at least one intravitreal injection of the biosimilar during the study period. Treatment regimens were determined by the treating physician and may have included an initial loading phase followed by pro re nata (PRN) or treat-and-extend (T\&E) protocols based on disease activity assessed by clinical examination and optical coherence tomography (OCT). The intervention was not assigned by the investigators, and no randomization or experimental treatment allocation was performed.

Locations (1)

Benha University

Banhā, Benha, Egypt

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