Investigating the effect of bevacizumab in reducing postoperative hemorrhage

Investigating the effect of intra-silicone bevacizumab injection in reducing vitreous hemorrhage after silicone oil drainage surgery in proliferative diabetic retinopathy patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231209060315N1

Enrollment

Registered

2024-01-19

Start date

2024-03-20

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Vitreous hemorrhage. Vitreous hemorrhage

Interventions

Intervention 1: Intervention group: In the case group, 5 to 10 days before silicone drainage surgery, an intra-silicone bevacizumab injection at a dose of 2.5 mg is performed. Intervention 2: Control

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age more than 18 y/o Patients with advanced proliferative diabetic retinopathy who have undergone vitrectomy surgery and silicone oil injection. Six months or more have passed since the vitrectomy and the patient is a candidate for silicone oil drainage surgery Totally attached retina.

Exclusion criteria

Exclusion criteria: Iris neovascularization Neovascular glaucoma Uncontrolled intraocular pressure Optic atrophy

Design outcomes

Primary

Measure	Time frame
Vitreous hemorrhage. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Examination.;Vitreous hemorrhage severity. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Examination.;Iris neovascularization. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Examination.;Neovascular glaucoma. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Slit-lamp examination and Goldman tonometery.;Retinal neovascularization. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Slit-lamp examination and indirect ophthalmoscopy.	—

Measure

Time frame

Vitreous hemorrhage. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Examination.;Vitreous hemorrhage severity. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Examination.;Iris neovascularization. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Examination.;Neovascular glaucoma. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Slit-lamp examination and Goldman tonometery.;Retinal neovascularization. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Slit-lamp examination and indirect ophthalmoscopy.

—

Secondary

Measure	Time frame
Retinal detachment. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Slit-lamp examination and indirect ophthalmoscopy.;Best Corrected Visual Acuity. Timepoint: Before intra-silicone injection, Days 1, 7, 30, and 90 after surgery. Method of measurement: Snellen chart.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHomayoun Nikkhah

Shahid Beheshti University of Medical Sciences

h.nikkhah52@gmail.com0098 77626550

Outcome results

None listed

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