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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Faricimab injection | Experimental | Patients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The 6-mg dose of faricimab will be administered by IVT at the study site to patients. A specified filter needle must be used for each dose preparation of faricimab according to the instructions provided in the Investigator's Brochure and package insert. No other material than specified should be used. Vials of faricimab drug product are for a single-dose only (one injection preparation per patient per eye). Vials used for one patient must not be used for any other patient. Partially used vials, remaining faricimab drug product, as well as administration material must not be reused. |
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| Sham injection | Sham Comparator | Patients will be randomized 2:1 to receive either farcimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection. The sham procedure mimics an intravitreal injection of faricimab except that the blunt end of an empty syringe is pressed against an anesthetized eye instead of a needle attached to a faricimab-filled syringe. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faricimab Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of post-operative vitreous hemorrhage | Following treatment and surgery, the development of vitreous hemorrhage will be quantified and evaluated. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA outcomes | Vision will be tested following treatment and surgery on the Snellen Chart, with or without correction as indicated. | 6 and 12 months |
| Rates of re-operation for non-clearing vitreous hemorrhage |
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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:
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sue Anschutz-Rodgers Eye Center | Aurora | Colorado | 80045 | United States |
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| sham treatment | Drug | Patients will be randomized 2:1 to receive either faricimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection |
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Following treatment and surgery, if re-operation for non-clearing vitreous hemorrhage is indicated, this will be track and quantified.
| 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. | 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. | Through study completion, an average of 1 year |
| Duration of operative time. | The official duration of surgical time will be quantified and evaluated. | 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. | 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. | 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. | intra-operatively |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000723200 | faricimab |
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