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NCT Number: NCT07690800

Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Benha University

Banhā, Benha, 13111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ranibizumab

Drug

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.

Primary outcomes

  1. Change in Best-Corrected Visual Acuity (BCVA)

    Time frame: Baseline through 6 months

    Change in BCVA from baseline to the end of follow-up, measured using Snellen visual acuity and converted to logMAR for statistical analysis.

Secondary outcomes

  1. Need for Additional Ranibizumab Injections

    Time frame: Baseline through 6 months

    Number and proportion of participants requiring reinjection based on persistent or incompletely resolved vitreous hemorrhage.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage: A Prospective Interventional Cohort Study

Acronym: RANI-VH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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