Clinical trial NCT06899529: Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
Official title: Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Proliferative Diabetic Retinopathy - High Risk
Keywords: proliferative diabetic retinopathy
bevacizumab
vitreous hemorrhage
Lead sponsor: Christian Ophthalmic Surgery Expedition Network
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Prospective Clinical Trial
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

1. Subject age is \> 18
2. Subject consents to study participation and is capable of 6 months of follow-up.
3. The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
4. Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to Hand Motions in the study eye.
5. 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.
6. Only one eye per patient is eligible for the study.

Exclusion Criteria:

1. 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.
2. 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.
3. Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
4. Subject has uncontrolled neovascular glaucoma (intraocular pressure \> 30 mmHg despite medical/surgical treatment) in the study eye.
5. Subject has uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.

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Primary outcomes:
measure: Primary Outcome
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Queretaro City
country: Mexico
facility: Sky Vision
state: Queretaro
Study officials:
affiliation: Christian Ophthalmic Surgery Expedition Network
name: Isaac Aleman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.