A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy
Study on Treatment Strategies for Proliferative Diabetic Retinopathy
Amir Hajrasouliha
Primary Investigator
Denis Jusufbegovic, MD
Primary Investigator
Brief description of study
This study will evaluate the safety and efficacy of two treatment strategies for PDR: faricimab plus PRP and Vitrectomy with endolaser with the goal to determine whether either approach decreases visit and treatment burden along with decreasing complications compared with the other treatment method while maintaining good visual acuity. The primary objectives of this study are to compare visual acuity at 3 years following vitrectomy with endolaser or faricimab+PRP and to compare number of treatments for PDR (i.e., injections, PRP, vitrectomy) following the end of randomized treatment over 3 years.
Detailed description of study
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Diabetes mellitus, Proliferative Diabetic Retinopathy, PDR
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Age: 18 years - 100 years
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Gender: All
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
This study investigates the treatment of proliferative diabetic retinopathy (PDR), which is an eye condition caused by diabetes that can lead to vision loss. The purpose of this study is to compare two treatment strategies: a combination of an investigational medication with panretinal photocoagulation (PRP) and a surgical procedure called vitrectomy with endolaser. The study aims to see how these treatments affect vision over time and their impact on the number of treatments needed.
Participants in the study will receive either the combination of the investigational medication and PRP or undergo vitrectomy with endolaser. The study will observe participants for three years to evaluate their visual acuity and the number of treatments they receive. This includes counting injections, surgeries, and any complications that arise during the study period.
- Who can participate: Adults aged 18 years or older with a diagnosis of diabetes mellitus (type 1 or type 2) and proliferative diabetic retinopathy requiring treatment can participate. Participants must have good enough vision (20/100 or better) and meet specific health criteria.
- Study details: Participants will either receive a combination of an investigational medication and PRP or undergo a vitrectomy with endolaser. They will be monitored for changes in visual acuity and treatment needs over three years.
- Study timelines: The study will last 3 years.
