Health Trials

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

ConditionProliferative Diabetic Retinopathy (PDR)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJaeb Center for Health Research

About this trial

This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.

Eligibility criteria

Qualifiers

≥ 18 years old

Diagnosis of diabetes mellitus (type 1 or type 2)

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)

Disqualifiers

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).

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.

Trial design

Treatments tested in this trial

  • Vitrectomy
  • Endolaser
  • Faricimab
  • Panretinal Photocoagulation (PRP)

Treatment groups

426 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jaeb Center for Health Research

Lead sponsor

National Eye Institute (NEI)

Collaborator

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov