NCT06790784 · Jaeb Center for Health Research
Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
(AP)
What this study is about
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. The participants will be followed for 3 years.
View original scientific description
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.
Interventions
PROCEDURE
Vitrectomy
The vitrectomy must occur within 4 weeks of randomization. A single injection of faricimab is allowed at any point before the vitrectomy. It is recommended that this injection is within 1 week of the vitrectomy. Requirement of triamcinolone staining to assist in complete elevation and removal of the posterior hyaloid and in removal of as much peripheral vitreous as is safely possible, 20 gauge not permitted. Allows subconjunctival steroid at investigator discretion; however, sub-tenon's triamcinolone or other long-acting steroid will not be permitted.
DEVICE
Endolaser
Complete panretinal photocoagulation (PRP) during vitrectomy
DRUG
Faricimab
Treatment must be initiated on the day of randomization with one faricumab injection. The remainder of the randomized treatment includes 2 additional injections every 4-weeks. Injections must be completed within 90 days of randomization.
DEVICE
Panretinal Photocoagulation (PRP)
Complete PRP. PRP may be completed in 1-3 sessions, with the timing at the investigator's discretion. All PRP sessions must be completed within 90 days of randomization.
Primary outcome measures
Visual Acuity Change from Baseline
Time frame: Baseline to 3- years
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40.
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy
Time frame: Over 3 Years
Initial randomized treatment will be excluded.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Huntington Beach, California
- Loma Linda, California
- Santa Barbara, California
- Jacksonville, Florida
- Lakeland, Florida
- Orlando, Florida
- Tampa, Florida
- Atlanta, Georgia
- Augusta, Georgia
- Sandy Springs, Georgia
- Oak Park, Illinois
- Carmel, Indiana
And 19 more locations — see the full list below.
Collaborators
National Eye Institute (NEI), Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations