Preoperative Bevacizumab and Ziv-Aflibercept Administration in PDR Subjects Undergoing PPV (NCT02590094) | Clinical Trial Compass
CompletedNot Applicable
Preoperative Bevacizumab and Ziv-Aflibercept Administration in PDR Subjects Undergoing PPV
Mexico568 participantsStarted 2015-10
Plain-language summary
To compare outcomes in subjects receiving different doses and treatment intervals of intravitreal bevacizumab or ziv-aflibercept preoperatively administered prior to undergoing vitrectomy for complications of proliferative diabetic retinopathy.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Subject age is 18-85 years.
✓. 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 light perception with projection 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 is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA 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.