Clinical trial NCT06191094: Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Diabetic Retinopathy
Vitreous Hemorrhage Due to Diabetes Mellitus
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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)

Primary outcomes:
measure: Rates of post-operative vitreous hemorrhage
timeFrame: 6 months
Secondary outcomes:
measure: BCVA outcomes
timeFrame: 6 and 12 months
measure: Rates of re-operation for non-clearing vitreous hemorrhage
timeFrame: 6 and 12 months
measure: Rate of post-operative epiretinal membrane formation.
timeFrame: Through study completion, an average of 1 year
measure: Rate of post-operative rhegmatogenous or tractional retinal detachment.
timeFrame: Through study completion, an average of 1 year
measure: Duration of operative time.
timeFrame: intra-operatively
measure: Number of endodiathermy use exchanges intra-operatively.
timeFrame: intra-operatively
measure: Number of retinal breaks intra-operatively.
timeFrame: intra-operatively
measure: Number of patients with intra-operative bleeding
timeFrame: intra-operatively
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Sue Anschutz-Rodgers Eye Center
state: Colorado
Study officials:
References: