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New treatment option for Proliferative Diabetic Retinopathy (PDR)
Official title Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
ClinicalTrials.gov ID: NCT06790784
What this study is testing
What is Faricimab?
Faricimab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for proliferative diabetic retinopathy (pdr).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser.
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)
You likely can't join if
- 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...
- 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...
- Traction retinal detachment involving the macula
See the full eligibility 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...
- Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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
- 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
- Rochester, Minnesota, United States
- Saint Louis Park, Minnesota, United States
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.