Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage: A Prospective Interventional Cohort Study
Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage: A Prospective Interventional Cohort Study
This prospective interventional cohort study evaluates the outcomes of intravitreal ranibizumab injection in patients with diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy. The study aims to assess the effectiveness of ranibizumab in improving visual acuity, promoting vitreous hemorrhage clearance, reducing the need for pars plana vitrectomy, and evaluating treatment-related safety.
Eligible adult patients with diabetic vitreous hemorrhage will receive intravitreal ranibizumab according to the study protocol and will be followed for 3 to 6 months with serial ophthalmic examinations. Outcome measures include changes in best-corrected visual acuity, vitreous hemorrhage severity, treatment-related complications, and the proportion of patients requiring vitrectomy. Panretinal photocoagulation may be performed when adequate retinal visualization is achieved.
Diabetic vitreous hemorrhage is a common vision-threatening complication of proliferative diabetic retinopathy. Hemorrhage into the vitreous cavity results from fragile retinal neovascularization and may cause marked visual impairment while preventing adequate retinal examination and laser treatment. Although pars plana vitrectomy remains the standard treatment for persistent or non-clearing vitreous hemorrhage, intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has emerged as a potential treatment option for selected patients.
Ranibizumab is a recombinant humanized monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), thereby reducing neovascular activity and vascular permeability. Suppression of VEGF may facilitate clearance of vitreous hemorrhage, improve visual acuity, allow subsequent panretinal photocoagulation, and reduce the need for vitrectomy.
This is a single-center prospective interventional cohort study conducted at the Ophthalmology Department of Benha University Hospital. Adult patients with diabetic vitreous hemorrhage who meet the eligibility criteria will receive intravitreal ranibizumab (0.5 mg/0.05 mL) under aseptic conditions. Patients will undergo comprehensive ophthalmic evaluation before treatment, including best-corrected visual acuity assessment, slit-lamp biomicroscopy, intraocular pressure measurement, fundus examination, and ocular imaging as clinically indicated, including optical coherence tomography, fluorescein angiography, or B-scan ultrasonography.
Participants will be followed after one week, one month, and monthly thereafter for 3 to 6 months. Additional ranibizumab injections may be administered after at least one month when clinically indicated. Panretinal photocoagulation may be performed once sufficient fundus visualization is obtained. Pars plana vitrectomy will be performed for worsening vitreous hemorrhage, persistent moderate or severe hemorrhage without adequate improvement, or the development of tractional retinal detachment involving the posterior pole.
The primary objectives are to evaluate improvement in best-corrected visual acuity and clearance of vitreous hemorrhage following intravitreal ranibizumab treatment. Secondary objectives include assessment of treatment-related adverse events and determination of the proportion of patients requiring pars plana vitrectomy during follow-up.
Inclusion Criteria:
Exclusion Criteria: