NCT07663370Completed
Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema
Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema: A Retrospective Observational Cohort Study
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 60 (actual)
- First submitted
- 17 Jun 2026
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Benha University
- Diseases
- Diabetic eye disease
- NCT number
- NCT07663370
What you commit to
- Study type: Observational
- Participants enrolled: 60
- From 1 Jan 2022 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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
Who the study is looking for
- • 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
Age in the registry: - to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Benha University Coordinator of this site? Confirm its status | Banhā | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.