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.

Exclusion Criteria:

- A potential participant is not eligible if any of the following exclusion criteria are
present:

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.