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Completed

NCT Number: NCT06559488

IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes

Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75%. Early and late recurrences are associated with various factors, including residual blood, fibrovascular tissue, and neovascularization. Despite attempts to reduce this complication with therapies like anti-fibrinolytic agents, gas tamponade, and peripheral cryotherapy, the outcomes remain unsatisfactory.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Eye Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Diseases Vascular Diseases Vitreous Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cicendo Eye Hospital

Bandung, Jawab Barat, 40117, Indonesia

About this study

Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant challenge with high incidence and negative impact on visual outcomes. Despite various treatments, intravitreal bevacizumab (IVB) has shown potential in reducing post-operative vitreous hemorrhage (PO-VH). This study aims to determine the efficacy and safety of intraoperative IVB in preventing PO-VH in patients undergoing vitrectomy for diabetic vitreous hemorrhage. This prospective, randomized controlled trial compared patients receiving intraoperative IVB to a control group. The primary outcome was PO-VH incidence at one month, with secondary outcomes including visual acuity change, time to VH clearance, and safety. Outcome assessors were masked to the study treatment. Data on demographics, medical history, visual acuity, VH grading, intraoperative findings, and postoperative complications will be collected. Statistical analysis compared PO-VH incidence and other outcomes between groups. This study will provide valuable evidence on the efficacy and safety of intraoperative IVB in preventing PO-VH, contributing to improved clinical practice and patient outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with spontaneous, non-clearing vitreous hemorrhage for at least one month as the initial vitrectomy indication for diabetic retinopathy.

Exclusion criteria

  • Patients with tractional retinal detachment (ART)
  • Patients with severe fibrovascular traction,
  • Patients with intravitreal gas or silicone oil tamponade at the end of surgery
  • Patients with other eye diseases besides diabetic vitreous hemorrhage
  • Patients with history of intravitreal bevacizumab injection in the last 3 months before surgery
  • Patients with other health condition includes uncontrolled hypertension, a history of coagulopathy
  • Patients with inability to attend follow-up examinations for at least 1 month
  • Patients taking anti-aggregation and anti-platelet medications with abnormal bleeding time (BT) and clotting time (CT)

Treatment and study plan

Bevacizumab Injection [Avastin]

Drug

Intravitreal bevacizumab (1.25 mg/0.05 mL) was injected at the completion of vitrectomy surgery.

Other names: Pars Plana Vitrectomy

pars plana vitrectomy

Procedure

routine procedure of pars plana vitrectomy in vitreous hemorrhage for proliferative diabetic retinopathy patients

Primary outcomes

  1. Incidence and Severity of Vitreal Hemorrhage Post-Operative

    Time frame: Day 1, 7, and 30

    Calculation of incidence of Vitreal Hemorrhage Post Operative based on grading (Grade 0, Grade 1, Grade 2, Grade 3, Grade 4) between two groups; higher grades are related to worse outcomes

Secondary outcomes

  1. Post operative visual Acuity, compared between groups

    Time frame: Day 1, 7, and 30

    Visual acuity measured with a Snellen chart was converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis. Snellen visual acuity of finger counting was categorized as log MAR 2.0, and hand motion as log MAR 3.0

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Collaborators

  • Cicendo Eye Hospital

Registry information

Official study title

Effects of Intravitreal Bevacizumab Intraoperatively in The Prevention of Early Recurrent Vitreous Hemorrhage Post-Vitrectomy in Diabetic Vitreous Hemorrhage

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2024
Registry last updated
Aug 27, 2024

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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