Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema

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.

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Key information

Conditions

Anti-VEGF Treatment Biosimilar Ranibizumab

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University

Banhā, Benha, 13111, Egypt

About this study

This study is a retrospective observational cohort designed to evaluate the real-world effectiveness and safety of intravitreal ranibizumab biosimilar in patients with diabetic macular edema (DME). Medical records of adult patients diagnosed with type 1 or type 2 diabetes mellitus who received at least one injection of ranibizumab biosimilar at the Retina Unit, Department of Ophthalmology, Benha University Hospitals, between January 2022 and April 2026 will be reviewed. Eligible cases will include eyes with center-involving DME confirmed by optical coherence tomography (OCT) and a minimum follow-up period of 3-6 months. Baseline demographic, systemic, and ocular characteristics, including age, sex, diabetes duration, HbA1c level, lens status, prior ocular treatment, best-corrected visual acuity (BCVA), and central macular thickness (CMT), will be collected. Follow-up data will include changes in BCVA and CMT, number of injections received, and treatment regimen (loading dose, pro re nata, or treat-and-extend protocols). Outcomes will assess mean changes in BCVA and CMT from baseline to final follow-up, as well as the proportion of eyes achieving clinically meaningful visual and anatomical improvement. Safety outcomes will include ocular adverse events such as endophthalmitis, intraocular inflammation, retinal detachment, and intraocular pressure elevation, as well as systemic thromboembolic events. Statistical analysis will be performed using SPSS software, with appropriate parametric or non-parametric tests applied based on data distribution, and a p-value <0.05 considered statistically significant. The study will be conducted following Institutional Review Board approval and in accordance with the Declaration of Helsinki, with all data anonymized to ensure patient confidentiality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranibizumab biosimilar

Drug

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.

Primary outcomes

Change in best-corrected visual acuity (BCVA)

Time frame: Baseline to final follow-up (minimum 3-6 months)

Mean change in best-corrected visual acuity (BCVA) from baseline to the final follow-up visit after intravitreal ranibizumab biosimilar treatment in patients with diabetic macular edema. BCVA will be recorded in Snellen or converted to ETDRS equivalent letters where applicable, and compared between baseline and post-treatment measurements.

Secondary outcomes

Change in central macular thickness (CMT)

Time frame: Baseline to final follow-up (minimum 3-6 months)

Mean change in central macular thickness (CMT) measured by optical coherence tomography (OCT) from baseline to final follow-up after intravitreal ranibizumab biosimilar treatment in eyes with diabetic macular edema.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: ERBDME

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Jun 23, 2026
Registry last updated: Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed