Last updated 2 months ago
Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
150 patients around the world
Available in Mexico
Proliferative Diabetic Retinopathy patients undergoing pars plana vitrectomy will be
randomized whether or not to receive intravitreal bevacizumab at the conclusion of the
operation.
Christian Ophthalmic Surgery Expedition Network
1Research sites
150Patients around the world
This study is for people with
Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Sky Vision
Recruiting
StudyPostop IVA
SponsorChristian Ophthalmic Surgery Expedition Network
Study typeInterventional
Conditions
Proliferative Diabetic Retinopathy
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06899529
