Clinical trial 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?
An investigational injectable medicine being studied for the treatment of 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
- The study compares long‑term vision outcomes, number of injections or procedures, complications, and cost between the two treatment options.
- Who it's for
- Adults with proliferative diabetic retinopathy.
- What's involved
- Participants are randomly assigned to receive either faricimab injections with panretinal photocoagulation (PRP) or a vitrectomy surgery followed by endolaser treatment. They will have regular eye exams and may receive additional injections or procedures as needed.
- Time commitment
- The study lasts 3 years, with scheduled visits for eye exams, injections or surgeries, and follow‑up assessments.
- 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
- ≥ 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
- 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.
- Traction retinal detachment involving the macula
- Significant vitreous hemorrhage that would preclude completion of a full PRP
See the full eligibility criteria
- ≥ 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)
- 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.
- 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 is enrolling
- Huntington Beach, California, United States
- Loma Linda, California, United States
- San Francisco, 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
- Chicago, Illinois, 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
+ 13 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, but 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?
This study is enrolling now at Huntington Beach, California, United States; Loma Linda, California, United States; San Francisco, California, United States; Santa Barbara, California, United States; Jacksonville, Florida, United States; Lakeland, Florida, United States and 27 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.