Stivant vs. Avastin in the treatment of retinopathy of prematurity

Non-inferiority trial comparing the efficacy and safety of biosimilar bevacizumab (Stivant, AryoGen, Iran) vs. bevacizumab (Avastin, Roche, Switzerland) intravitreal injection in the treatment of retinopathy of prematurity

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180905040958N1

Enrollment

Registered

2020-11-17

Start date

2020-02-20

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

Retinopathy of Prematurity. Retinopathy of prematurity

Interventions

Intervention 1: Intraocular injection of bevacizumab (Avastin, Roche, Switzerland) in the left eye at a dose of 0.625mg/0.025mL. Intervention 2: Intraocular injection of biosimilar bevacizumab (Stivan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Neonates weighing 2,000 grams or less with gestational age of 34 weeks or less Diagnosis of type 1 prethreshold retinopathy of prematurity Signed informed consent form

Exclusion criteria

Exclusion criteria: Cataract, congenital glaucoma, or any ocular disease other than ROP

Design outcomes

Primary

Measure	Time frame
Percentage of patients with the need for laser treatment or re-injection. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Imaging with RetCam device and clinical exam.	—

Secondary

Measure	Time frame
Time for reduction or disappearance of vascular tortuosity in Plus disease. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Imaging with RetCam device and clinical exam.;Retinal neovascularization regression time. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Imaging with RetCam device and clinical exam.;Retinal vascularization completion time. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Imaging with RetCam device and clinical exam.;Incidence rate of adverse drug reactions - intraocular inflammation. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Clinical exam.;Incidence rate of adverse drug reactions - intraocular infection. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Clinical exam.	—

Measure

Time frame

Time for reduction or disappearance of vascular tortuosity in Plus disease. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Imaging with RetCam device and clinical exam.;Retinal neovascularization regression time. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Imaging with RetCam device and clinical exam.;Retinal vascularization completion time. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Imaging with RetCam device and clinical exam.;Incidence rate of adverse drug reactions - intraocular inflammation. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Clinical exam.;Incidence rate of adverse drug reactions - intraocular infection. Timepoint: Weekly in the first month of the study and fortnightly in the next two months. Method of measurement: Clinical exam.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Abrishami

Mashhad University of Medical Sciences

abrishamimo@mums.ac.ir+98 51 3728 9911

Outcome results

None listed

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