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Completed NCT07663370

Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema

Conditions: Anti-VEGF Treatment, Ranibizumab, Biosimilar

Sex: All
Ages: N/A – 80 Years
Healthy volunteers: No
Enrollment: 60
Sponsor: Benha University

Location: Benha University Banhā Benha

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.

Eligibility Criteria

Inclusion Criteria: * • Age ≥18 years * Diagnosis of type 1 or type 2 diabetes mellitus * Center-involving diabetic macular edema confirmed by OCT * Received at least one intravitreal ranibizumab biosimilar injection * Minimum follow-up duration of 3-6 months Exclusion Criteria: * • Macular edema due to causes other than diabetes * Prior anti-VEGF treatment within specified washout period * Significant media opacity affecting imaging * Coexisting retinal pathology affecting vision (e.g., AMD, RVO) * Prior vitreoretinal surgery * Incomplete records or inadequate follow-up

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07663370). StuddyBuddy aggregates publicly available trial information.