Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema

NCT07663370 | Completed DMC

• 1 other identifier: DME-RANIBIZUMAB-BIOSIMILAR-202
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anti-VEGF Treatment; Ranibizumab; Biosimilar

Keywords

Diabetic macular edema; ranibizumab biosimilar; anti-VEGF therapy; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Change in best-corrected visual acuity (BCVA)

  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.

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

Secondary Outcomes (1)

• Change in central macular thickness (CMT)

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

Study Arms (1)

Ranibizumab biosimilar treatment group

This cohort includes adult patients with type 1 or type 2 diabetes mellitus diagnosed with center-involving diabetic macular edema confirmed by optical coherence tomography (OCT), who received at least one intravitreal injection of ranibizumab biosimilar during the study period. All data are obtained retrospectively from medical records at the Retina Unit, Department of Ophthalmology, Benha University Hospitals. Patients were managed according to routine clinical practice using ranibizumab biosimilar administered via intravitreal injection, with treatment regimens including loading doses, pro re nata (PRN), or treat-and-extend (T\&E) protocols as determined by the treating physician. No control or comparator group is included in this observational study. Outcomes of interest include changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), injection burden, and the incidence of ocular and systemic adverse events during follow-up.

Drug: Ranibizumab biosimilar

Interventions

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.

Ranibizumab biosimilar treatment group

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 1 or type 2 diabetes mellitus diagnosed with center-involving diabetic macular edema confirmed by optical coherence tomography (OCT), who received at least one intravitreal injection of ranibizumab biosimilar at the Retina Unit, Department of Ophthalmology, Benha University Hospitals, between January 2022 and April 2026. Eligible eyes had a minimum follow-up duration of 3-6 months with available baseline and follow-up data for best-corrected visual acuity (BCVA) and central macular thickness (CMT). Patients with other causes of macular edema, prior recent anti-VEGF therapy within the washout period, significant media opacity affecting imaging, coexisting retinal pathology affecting vision, prior vitreoretinal surgery, or incomplete records were excluded. The population reflects a real-world retrospective cohort treated in routine clinical practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: January 1, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 15, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

EG (1)