Anti-VEGF vs. Prompt Vitrectomy for VH From PDR

Inclusion Criteria

• •1. Age \>= 18 years Participants \<18 years old are not being included because proliferative diabetic retinopathy is so rare in this age group that the diagnosis may be questionable.
• •2. Diagnosis of diabetes mellitus (type 1 or type 2)
• •Any one of the following will be considered to be sufficient evidence that diabetes is present:
• •Current regular use of insulin for the treatment of diabetes
• •Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
• •Documented diabetes by American Diabetes Association and/or World Health Organization criteria 4. Able and willing to provide informed consent. 5. Patient is willing and able to undergo vitrectomy within next 2 weeks and the vitrectomy can be scheduled within that time frame.
• •6\. Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, for which intervention is deemed necessary.
• •* Note: Prior panretinal photocoagulation is neither a requirement nor an exclusion.
• •* Subhyaloid hemorrhage alone does not make an eye eligible; however, presence of subhyaloid hemorrhage in addition to the criteria above will not preclude participation provided the investigator is comfortable with either treatment regimen.
• •7\. Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 months to see if hemorrhage clears sufficiently with anti-vascular endothelial growth factor without having to proceed to vitrectomy).
• •8\. Visual acuity letter score ≤78 (approximate Snellen equivalent 20/32) and at least light perception.
• •9\. Investigators should use particular caution when considering enrollment of an eye with visual acuity letter score 69 to 78 (approximate Snellen equivalent 20/32 to 20/40) to ensure that the need for vitrectomy and its potential benefits outweigh the potential risks.
• •1. History of chronic renal failure requiring dialysis (including placement of fistula if performed in preparation for dialysis) or kidney transplant.
• •2. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• •3. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.
• •4. A condition that, in the opinion of the investigator, would preclude participant undergoing elective vitrectomy surgery if indicated during the study.
• •5. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.
• •• Note: participants cannot receive another investigational drug while participating in the study.
• •6. Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine).
• •7. Blood pressure \> 180/110 (systolic above 180 or diastolic above 110).
• •8. If blood pressure is brought below 180/110 by anti-hypertensive treatment, potential participant can become eligible.
• •9. Systemic anti-vascular endothelial growth factor or pro-vascular endothelial growth factor treatment within 4 months prior to randomization.
• •• These drugs cannot be used during the study.
• •10. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next two years.
• •• Women who are potential participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
• •11. Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the two years.
• •12. Evidence of traction detachment involving or threatening the macula.
• •• If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.
• •13. Evidence of rhegmatogenous retinal detachment.
• •• If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.
• •14. Evidence of neovascular glaucoma (iris or angle neovascularization is not an exclusion).
• •15. Known diabetic macular edema (DME), defined as either
• •16. Optical coherence tomography central subfield thickness (microns):
• •17. Zeiss Cirrus: ≥290 in women; ≥305 in men
• •18. Heidelberg Spectralis: ≥305 in women; ≥320 in men OR
• •19. Diabetic macular edema on clinical exam that the investigator believes currently requires treatment.
• •20. History of intravitreous anti-vascular endothelial growth factor treatment within 2 months prior to current vitreous hemorrhage onset or after onset.
• •21. History of intraocular corticosteroid treatment within 4 months prior to current vitreous hemorrhage onset or after onset.
• •22. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months following randomization.
• •23. History of vitrectomy.
• •24. History of YAG capsulotomy performed within 2 months prior to randomization.
• •25. Aphakia.
• •26. Uncontrolled glaucoma (in investigator's judgment).
• •27. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.