Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR

Korábbi kezelés

• Individual:
  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  • Blood pressure > 160/100 (systolic above 160 or diastolic above 100).
  • o If blood pressure is brought below 160/100 by anti-hypertensive treatment, individual can become eligible.
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
  • Women of childbearing potential will be required to have pregnancy testing or use an acceptable method of pregnancy prevention. Women who are potential study participants should be questioned about the potential for pregnancy at baseline and prior to each injection. Pregnancy test is required for all women of childbearing potential at baseline. Investigator judgment is used to determine when a pregnancy test is needed during follow up.
  • Study Eye: (A participant can have two study eyes.)
• Any prior vitrectomy
• Any prior PRP (defined as ≥100 burns outside of the posterior pole)
• Treatment for DME within the prior 6 months
• Intravitreal anti-VEGF for any indication, other than DME, within the prior year

Más betegség

• Significant vitreous hemorrhage that would preclude completion of a full PRP

Egyéb

• Traction retinal detachment involving the macula
• Significant vitreomacular traction

• Individual:
• ≥ 18 years old
• Diagnosis of diabetes mellitus (type 1 or type 2)
  • Study Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)
• Presence of PDR requiring treatment, defined as moderate PDR or worse on global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse on global grading of ultrawide field FA, confirmed by a central reading center
• Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)