A Phase 4 interventional study of Ranibizumab in Diabetic Vitreous Hemorrhage, Intravitreal Injections and Ranibizumab, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Benha University · Phase 4, Interventional, and Treatment
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.
Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
Participants with diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy receive intravitreal ranibizumab (0.5 mg/0.05 mL). Reinjection may be performed at least one month after the initial injection if clinically indicated. Participants are followed for 3 to 6 months to assess visual acuity, vitreous hemorrhage clearance, treatment-related adverse events, and the need for pars plana vitrectomy. Panretinal photocoagulation may be performed when adequate fundus visualization is achieved.
Drug: Ranibizumab
Ranibizumab (0.5 mg/0.05 mL) is administered by intravitreal injection under aseptic conditions. Before injection, topical anesthetic and 5% povidone-iodine are applied. The injection is performed using a 30-gauge needle through the inferotemporal pars plana approximately 4 mm posterior to the limbus. Additional injections may be administered after at least one month according to clinical response.
Change in Best-Corrected Visual Acuity (BCVA)
Change in BCVA from baseline to the end of follow-up, measured using Snellen visual acuity and converted to logMAR for statistical analysis.
Time frame: Baseline through 6 months
Need for Additional Ranibizumab Injections
Number and proportion of participants requiring reinjection based on persistent or incompletely resolved vitreous hemorrhage.
Time frame: Baseline through 6 months
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Benha University