Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06899529

Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy

Patients undergoing surgery for complications related to diabetes will be recruited.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Proliferative Diabetic Retinopathy patients undergoing pars plana vitrectomy will be randomized whether or not to receive intravitreal bevacizumab at the conclusion of the operation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject age is > 18
  • Subject consents to study participation and is capable of 6 months of follow-up.
  • The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
  • Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to Hand Motions in the study eye.
  • The subject is determined to need a PPV because of reduced BCSVA principally from a non-clearing vitreous hemorrhage, TRD, fibrous proliferation, or a combination of the three. When non-clearing vitreous hemorrhage is the principal reason for PPV, the hemorrhage must have been present by subjective history for at least 3 months. When TRD is the principal reason for PPV, the TRD must be threatening (within one disc diameter) or involving the fovea. When fibrovascular proliferation is the principal reason for PPV, it must be extensive (>3 clock hours) and threatening (within one disc diameter) or involving the fovea.
  • Only one eye per patient is eligible for the study.

Exclusion criteria

  • Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
  • Subject has a significant corneal opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
  • Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
  • Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
  • Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.

-

Treatment and study plan

Bevacizumab

Procedure

Bevacizumab will be given immediately after surgery in the Treatment Group

Primary outcomes

  1. Primary Outcome

    Time frame: 6 months

    Postoperative vitreous hemorrhage rate

Study contacts

Contact information is provided by the study sponsor or research team.

Christi Rush

CONTACT

8066740200

Ryan Rush, MD

CONTACT

[email protected]

18066740200

Sponsors and collaborators

Lead sponsor

Christian Ophthalmic Surgery Expedition Network

Other

Registry information

Acronym: Postop IVA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

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.

Published trials that share one or more normalized conditions with this study.