Diabetic Retinopathy, Vitreous Hemorrhage Due to Diabetes Mellitus
Conditions
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.
Interventions
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.
DRUGsham 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
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of post-operative vitreous hemorrhage | 6 months | Following treatment and surgery, the development of vitreous hemorrhage will be quantified and evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA outcomes | 6 and 12 months | Vision will be tested following treatment and surgery on the Snellen Chart, with or without correction as indicated. |
| Rates of re-operation for non-clearing vitreous hemorrhage | 6 and 12 months | Following treatment and surgery, if re-operation for non-clearing vitreous hemorrhage is indicated, this will be track and quantified. |
| Rate of post-operative epiretinal membrane formation. | Through study completion, an average of 1 year | Following treatment and surgery, the duration of time if a patient was to develop an epiretinal membrane will be quantified and evaluated. |
| Rate of post-operative rhegmatogenous or tractional retinal detachment. | Through study completion, an average of 1 year | 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. |
| Duration of operative time. | intra-operatively | The official duration of surgical time will be quantified and evaluated. |
| Number of endodiathermy use exchanges intra-operatively. | intra-operatively | At the time of surgery, the number of endodiathermy use exchanges will be counted and evaluated. |
| Number of retinal breaks intra-operatively. | intra-operatively | At the time of surgery, the number of retinal breaks intra-operatively will be counted and evaluated. |
| Number of patients with intra-operative bleeding | intra-operatively | At the time of surgery, the number of patients who experience intra-operative bleeding will be counted and evaluated. |
Countries
United States
Outcome results
None listed