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

RecruitingPhase 3

Sponsor: Jaeb Center for Health Research

Conditions: Proliferative Diabetic Retinopathy (PDR)

Interventions: Vitrectomy, Endolaser, Faricimab, Panretinal Photocoagulation (PRP)

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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)

Exclusion Criteria:

* 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.)

* Traction retinal detachment involving the macula
* Significant vitreous hemorrhage that would preclude completion of a full PRP
* Significant vitreomacular traction
* 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

Locations (32)

Huntington Beach, California, United States
Loma Linda, California, United States
Santa Barbara, California, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Sandy Springs, Georgia, United States
Oak Park, Illinois, United States
Carmel, Indiana, United States
Indianapolis, Indiana, United States
West Des Moines, Iowa, United States
Overland, Kansas, United States
Lexington, Kentucky, United States
West Monroe, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Saint Louis Park, Minnesota, United States
St Louis, Missouri, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Edmond, Oklahoma, United States
Monroeville, Pennsylvania, United States
Austin, Texas, United States
Bellaire, Texas, United States
Dallas, Texas, United States
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