Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy

NCT06899529 | Recruiting DMC

• 1 other identifier: IORG0009239-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Proliferative Diabetic Retinopathy - High Risk

Keywords

proliferative diabetic retinopathy; bevacizumab; vitreous hemorrhage

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Postoperative vitreous hemorrhage rate

  6 months

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Receives postoperative bevacizumab

Procedure: Bevacizumab

Control Group

NO INTERVENTION

Does NOT receive postoperative bevacizumab

Interventions

Bevacizumab PROCEDURE

Bevacizumab will be given immediately after surgery in the Treatment Group

Treatment Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Ophthalmic Surgery Expedition Network: lead

Study Sites (1)

Sky Vision

Querétaro City, Querétaro, 76165, Mexico

RECRUITING

Related Publications (3)

• Aleman I, Castillo Velazquez J, Rush SW, Rush RB. Ziv-aflibercept versus bevacizumab administration prior to diabetic vitrectomy: a randomised and controlled trial. Br J Ophthalmol. 2019 Dec;103(12):1740-1746. doi: 10.1136/bjophthalmol-2018-313313. Epub 2019 Jan 31.

  PMID: 30705040 BACKGROUND

• Castillo Velazquez J, Aleman I, Rush SW, Rush RB. Bevacizumab before Diabetic Vitrectomy: A Clinical Trial Assessing 3 Dosing Amounts. Ophthalmol Retina. 2018 Oct;2(10):1010-1020. doi: 10.1016/j.oret.2018.04.014. Epub 2018 Oct 3.

  PMID: 31047488 BACKGROUND

• Castillo J, Aleman I, Rush SW, Rush RB. Preoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: A Randomized and Controlled Trial Comparing Interval Variation. Am J Ophthalmol. 2017 Nov;183:1-10. doi: 10.1016/j.ajo.2017.08.013. Epub 2017 Aug 30.

  PMID: 28860046 BACKGROUND

MeSH Terms

Conditions

Vitreous Hemorrhage

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Eye Hemorrhage; Eye Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Isaac Aleman, MD

  Christian Ophthalmic Surgery Expedition Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Rush, MD

CONTACT

18066740200; chosenmedical@gmail.com

Christi Rush

CONTACT

8066740200

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and the specialist recording outcomes will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Prospective Clinical Trial

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

ME (1)