Phase 3: testing Faricimab for Proliferative Diabetic Retinopathy (PDR)
This randomly assigned trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser.
Official registry: https://clinicaltrials.gov/study/NCT06790784 · Jaeb Center for Health Research · enrollment listed as 426
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Vitrectomy, Endolaser, or Faricimab. The registry lists allocation as randomized. This randomly assigned trial will compare treatment strategies for proliferative diabetic retinopathy (PDR).
They plan to enroll about 426 people at 34 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device, a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy
Interventions: Vitrectomy, Endolaser, Faricimab, Panretinal Photocoagulation (PRP)
Primary outcome (registry wording): Visual Acuity Change from Baseline
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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)
Who the registry excludes
- 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
- Study Eye: (A participant can have two study eyes.)
- Traction retinal detachment involving the macula
- Significant vitreous hemorrhage that would preclude completion of a full PRP
Public study contact (from the registry)
Cynthia Stockdale
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
34 listed- Retina Associates of Southern California — Huntington Beach, California (recruiting)
- Loma Linda University — Loma Linda, California (recruiting)
- West Coast Retina Medical Group, Inc. — San Francisco, California (recruiting)
- California Retina Consultants — Santa Barbara, California (recruiting)
- University of Florida - Jacksonville — Jacksonville, Florida (recruiting)
- Florida Retina Consultants — Lakeland, Florida (recruiting)
- Ophthalmic Partners of Florida, PA dba Central Florida Retina — Orlando, Florida (recruiting)
- Retina Associates of Florida, LLC — Tampa, Florida (recruiting)
- Emory Eye Center — Atlanta, Georgia (recruiting)
- Southeast Retina Center, P.C. — Augusta, Georgia (recruiting)
- Thomas Eye Group — Sandy Springs, Georgia (recruiting)
- Rush University Medical Center — Chicago, Illinois (recruiting)
FAQ about this NCT record
Is NCT06790784 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06790784?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06790784?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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