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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
100
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.
Patients will be randomized 2:1 to receive either faricimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection
Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, United States
Rates of post-operative vitreous hemorrhage
Following treatment and surgery, the development of vitreous hemorrhage will be quantified and evaluated.
Time frame: 6 months
BCVA outcomes
Vision will be tested following treatment and surgery on the Snellen Chart, with or without correction as indicated.
Time frame: 6 and 12 months
Rates of re-operation for non-clearing vitreous hemorrhage
Following treatment and surgery, if re-operation for non-clearing vitreous hemorrhage is indicated, this will be track and quantified.
Time frame: 6 and 12 months
Rate of post-operative epiretinal membrane formation.
Following treatment and surgery, the duration of time if a patient was to develop an epiretinal membrane will be quantified and evaluated.
Time frame: Through study completion, an average of 1 year
Rate of post-operative rhegmatogenous or tractional retinal detachment.
Following treatment and surgery, the duration of time if a patient was to develop a rhegmatogenous or tractional retinal detachment will be quantified and evaluated.
Time frame: Through study completion, an average of 1 year
Duration of operative time.
The official duration of surgical time will be quantified and evaluated.
Time frame: intra-operatively
Number of endodiathermy use exchanges intra-operatively.
At the time of surgery, the number of endodiathermy use exchanges will be counted and evaluated.
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Time frame: intra-operatively
Number of retinal breaks intra-operatively.
At the time of surgery, the number of retinal breaks intra-operatively will be counted and evaluated.
Time frame: intra-operatively
Number of patients with intra-operative bleeding
At the time of surgery, the number of patients who experience intra-operative bleeding will be counted and evaluated.
Time frame: intra-operatively