Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage (RANI-VH)

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.

Study Overview

• Status: Completed
• Conditions: Intravitreal Injections; Ranibizumab; Diabetic Vitreous Hemorrhage
• Intervention / Treatment: Drug: Ranibizumab

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Benha
    • Banhā, Benha, Egypt, 13111
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 20 to 70 years.
• Type 1 or Type 2 diabetes mellitus.
• Diabetic vitreous hemorrhage secondary to proliferative diabetic retinopathy.
• Treatment-naïve diabetic vitreous hemorrhage or recurrent/residual vitreous hemorrhage following previous panretinal photocoagulation.
• Phakic or pseudophakic eyes.
• Able and willing to provide written informed consent.

Exclusion Criteria:

• Significant tractional retinal detachment or retinal traction requiring immediate surgery.
• Previous ocular surgery other than cataract surgery.
• Previous intravitreal pharmacologic treatment within the preceding 6 months.
• Any type of glaucoma.
• Active ocular infection or significant ocular surface disease.
• No light perception vision.
• Known hypersensitivity to ranibizumab or any component of the study medication.
• Refusal or inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intravitreal Ranibizumab; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Additional Ranibizumab Injections	Number and proportion of participants requiring reinjection based on persistent or incompletely resolved vitreous hemorrhage.	Baseline through 6 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Proliferative Diabetic Retinopathy; Ranibizumab; Anti-VEGF; Pars Plana Vitrectomy; Diabetic Vitreous Hemorrhage
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ranibizumab
• Other Study ID Numbers: BENHA-OPH-2025-RANI-VH-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No