IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes

August 24, 2024 updated by: Universitas Padjadjaran

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jawab Barat
      • Bandung, Jawab Barat, Indonesia, 40117
        • Cicendo Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab Intravitreal
Ten patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed. Post-vitrectomy, 1.25 mg bevacizumab injected via 30-gauge needle in superotemporal or inferotemporal pars plana.
Drug: Bevacizumab Injection [Avastin]
Intravitreal bevacizumab (1.25 mg/0.05 mL) was injected at the completion of vitrectomy surgery.
Other Names:
  • Pars Plana Vitrectomy
Procedure: Pars Plana Vitrectomy
routine procedure of pars plana vitrectomy in vitreous hemorrhage for proliferative diabetic retinopathy patients
Experimental: Control
Eight patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed.
Procedure: Pars Plana Vitrectomy
routine procedure of pars plana vitrectomy in vitreous hemorrhage for proliferative diabetic retinopathy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1, 7, and 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1, 7, and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Collaborators

Cicendo Eye Hospital

Investigators

  • Principal Investigator: Mohamad Eko Prayogo, MD, Faculty of Medicine Universitas Padjadjaran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHTH-202408.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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