The Comparison of Efficacy Between Iranian Made Ranibizumab and Imported Ranibizumab in Diabetic Patients with Macular Edema

The Comparison of the Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis®) with Imported Ranibizumab (Lucentis®) in Patients with Diabetic Macular Edema: A phase III, Two-armed, Double-blind, Parallel, Active-controlled, and Noninferiority Clinical Randomized Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170303032845N1

Enrollment

154

Registered

2019-02-03

Start date

2019-12-22

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic retinopathy. Type 1 diabetes mellitus with ophthalmic complications

Interventions

Intervention 1: Intervention group: An intravitreal injection of 0.05 ml Ranibizumab (Aracell zist daru). Intervention 2: Control group: An intravitreal injection of 0.05 ml Ranibizumab (Roche).

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Diabetes mellitus type 1 or 2 Center involving macular edema with a central subfield thickness (CST) of >300 Early treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity letter score of 24 to 78 (20/32 to 20/400) HbA1c<9% Blood Pressure <150/100 Triglyceride and LDL up to 20% higher than upper normal limits Pseudophakic patients are allowed to enter the study. Signed written inform consent

Exclusion criteria

Exclusion criteria: History of intravitreal injection within the past 2 months History of any ocular surgery within the past 6 months History of glaucoma or ocular hypertension Any media opacity in the cornea, lens and vitreous body which interferes with eye examination and imaging. Monocular patients Pregnant or breastfeeding women Proliferative diabetic retinopathy (PDR) with high-risk characteristics HbA1c>10% Smoking (more than 10 cigarettes per day) Use of acetazolamide tablets or intraocular pressure-lowering drops Use of systemic corticosteroids or nonsteroidal anti-inflammatory eye drops (NSAIDs)

Design outcomes

Primary

Measure	Time frame
Central macular thickness. Timepoint: At the beginning of the study (before the intervention), 30 days after injection. Method of measurement: Optical coherence tomography.	—

Secondary

Measure	Time frame
Visual acuity. Timepoint: At the beginning of the study (before the intervention), 7 and 30 days after injection. Method of measurement: Snellen chart.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSayyed Amirpooya Alemzadeh

Iran University of Medical Sciences

s.amirpooya.alemzadeh@gmail.com+98 21 6655 8811

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026