Outcomes of Intravitreal Ranibizumab Injection for Diabetic Vitreous Hemorrhage

NCT07690800 | Completed Phase 4 DMC

• 1 other identifier: BENHA-OPH-2025-RANI-VH-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Vitreous Hemorrhage; Intravitreal Injections; Ranibizumab

Keywords

Diabetic Vitreous Hemorrhage; Proliferative Diabetic Retinopathy; Ranibizumab; Anti-VEGF; Pars Plana Vitrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Need for Additional Ranibizumab Injections

  Baseline through 6 months

Study Arms (1)

Intravitreal Ranibizumab

EXPERIMENTAL

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

Interventions

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.

Intravitreal Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This is a prospective, single-center, single-arm interventional cohort study in which all eligible participants receive intravitreal ranibizumab injection. Participants are followed for 3 to 6 months to evaluate visual and anatomical outcomes, treatment-related complications, and the need for pars plana vitrectomy.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start: April 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 1, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

EG (1)