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

Официальное название

A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy

Обзор

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.

Подробное описание

Although some combination of anti-VEGF plus PRP is the most common treatment approach for PDR with and without DME, there are currently no long-term data on a standardized approach. Vitrectomy is not currently used as first-line treatment for early PDR but advances in surgical technique have reduced associated complications and the ability to remove the posterior hyaloid during surgery may have advantages over nonsurgical approaches, especially in the reduction of vitreous hemorrhage and/or traction retinal detachment that may occur later when the hyaloid separates naturally. Protocol S demonstrated both PRP and anti-VEGF alone result in good visual acuity results long-term so it is expected that a combination treatment would also result in good visual acuity results.

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.

Вмешательства

• Процедура 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 triamcin
• Устройство Endolaser
  Complete panretinal photocoagulation (PRP) during vitrectomy
• Препарат 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.
• Устройство 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.

Первичные конечные точки

• Visual Acuity Change from Baseline [Срок оценки: Baseline to 3- years]
• Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy [Срок оценки: Over 3 Years]

Критерии участия

Критерии включения

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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 30 центров

• Retina Associates of Southern California — Huntington Beach
• Loma Linda University — Loma Linda
• California Retina Consultants — Santa Barbara
• University of Florida - Jacksonville — Jacksonville
• Florida Retina Consultants — Lakeland
• Ophthalmic Partners of Florida, PA dba Central Florida Retina — Orlando
• Retina Associates of Florida, LLC — Tampa
• Emory Eye Center — Atlanta
• … и ещё 22 центра

Идентификаторы

NCT: NCT06790784 · Protocol AP · UG1EY014231

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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