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