Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy

Официальное название

A Randomized, Double-masked, Sham-controlled Study to Evaluate the Efficacy of Peri-operative Farcimab in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy

Обзор

In this phase IV, randomized, double-masked, sham-controlled study the investigators hope to determine the efficacy in peri-operative faricimab (Vabysmo) compared to sham in limiting complications from pars plana vitrectomy for diabetic vitreous hemorrhage with or without tractional retinal detachments.

Вмешательства

• Препарат Faricimab Injection
  Pre-operative injection of bevacizumab appears to have mixed results in lowering post-operative vitreous hemorrhage. One potential reason is due to aspiration and removal of medication in the vitreous humor at the time of pars plana vitrectomy leading to less than anticipated results in controlling neovascularization and vitreous hemorrhage post-operatively. To avoid attenuation of our desired effect we plan to repeat faricimab injection post-operatively around week one.
• Препарат sham treatment
  Patients will be randomized 2:1 to receive either faricimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection

Первичные конечные точки

• Rates of post-operative vitreous hemorrhage [Срок оценки: 6 months]

Вторичные конечные точки (8)

• BCVA outcomes [Срок оценки: 6 and 12 months]
• Rates of re-operation for non-clearing vitreous hemorrhage [Срок оценки: 6 and 12 months]
• Rate of post-operative epiretinal membrane formation. [Срок оценки: Through study completion, an average of 1 year]
• Rate of post-operative rhegmatogenous or tractional retinal detachment. [Срок оценки: Through study completion, an average of 1 year]
• Duration of operative time. [Срок оценки: intra-operatively]
• Number of endodiathermy use exchanges intra-operatively. [Срок оценки: intra-operatively]
• Number of retinal breaks intra-operatively. [Срок оценки: intra-operatively]
• Number of patients with intra-operative bleeding [Срок оценки: intra-operatively]

Критерии участия

Критерии включения

Patients must meet the following criteria for study entry:

• Signed Informed Consent Form
• Age ≥ 18 years at time of signing Informed Consent Form
• Ability to comply with the study protocol, in the investigator's judgment
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:

• Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for 3 months after the final dose of the study drug.
• A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).
• Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
• The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Ocular inclusion criteria for study eye:

● Patients diagnosed with non-clearing vitreous hemorrhage with or without tractional retinal detachment secondary to proliferative diabetic retinopathy and undergoing pars plana vitrectomy

Критерии исключения

General:

Patients who meet any of the following general exclusion criteria will be excluded from study entry:

• Any known hypersensitivity to any of the components in the faricimab injection
• Any known hypersensitivity to any dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used during the study
• History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, or historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the faricimab or that might affect interpretation of the results of the study or renders the patient at high-risk for treatment complications, in the opinion of the investigator
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab Women of childbearing potential must have a negative urine pregnancy test result at baseline prior to initiation of dosing of faricimab/sham and a negative urine pregnancy test at post-op Week 1 prior to dosing of faricimab/sham

Ocular exclusion criteria for study eye:

Patients who meet any of the following exclusion criteria for the study eye will be excluded from study entry:

• Any ocular anti-VEGF treatment within 3 months prior to Day 1 (Baseline) in the study eye
• Vitreous hemorrhage or tractional retinal detachment suspected due to cause other than diabetic retinopathy
• Any glaucoma surgery in the study eye prior to the Day 1 (Baseline) visit
• History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy in study eye
• Uncontrolled glaucoma (e.g., progressive loss of visual fields or defined as intraocular pressure (IOP) ≥25 mmHg at the Day 1 (Baseline) visit despite treatment with anti-glaucoma medication)
• Any history of idiopathic, infectious, or noninfectious uveitis
• Any current or history of ocular disease other than diabetic retinopathy that may confound assessment of the macula or affect central vision (e.g., age-related macular degeneration, retinal vein occlusion, angioid streaks, histoplasmosis, active or inactive cytomegalovirus retinitis, pathological myopia, retinal detachment, macular traction, retinal embolus, macular hole)

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

Поддерживающая терапия

Центры проведения

США · 1 центр

• Sue Anschutz-Rodgers Eye Center — Aurora

Идентификаторы

NCT: NCT06191094 · 23-0483

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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