Vabysmo for Diabetic Retinopathy
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using any ocular anti-VEGF treatments, you must stop them at least 3 months before starting the trial.
What data supports the effectiveness of the drug Vabysmo (Faricimab) for treating diabetic retinopathy?
Research shows that Faricimab, marketed as Vabysmo, has been effective in improving vision and reducing retinal thickness in patients with diabetic macular edema, a condition related to diabetic retinopathy. In clinical trials, Faricimab demonstrated similar or better results compared to other treatments, with fewer injections needed, indicating its potential effectiveness for diabetic retinopathy.12345
Is Vabysmo (Faricimab) safe for humans?
Vabysmo (Faricimab) has been studied in several clinical trials for conditions like diabetic macular edema and neovascular age-related macular degeneration, showing a good safety profile. These studies indicate that it is generally safe for human use, with safety data supporting its approval in the USA and Japan.12367
What makes the drug Vabysmo unique for treating diabetic retinopathy?
What is the purpose of this trial?
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
This trial is for adults over 18 with non-clearing vitreous hemorrhage due to diabetic retinopathy, who are undergoing eye surgery. They must be able to follow the study plan and use effective contraception if of childbearing potential. Those unable to commit or at risk of not complying with contraceptive guidelines are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive peri-operative faricimab or sham injection to evaluate efficacy in limiting complications from pars plana vitrectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including BCVA outcomes and rates of post-operative complications
Treatment Details
Interventions
- Faricimab
Faricimab is already approved in United States, European Union, Canada for the following indications:
- Neovascular age-related macular degeneration (nAMD)
- Diabetic macular edema (DME)
- Macular edema following retinal vein occlusion (RVO)
- Neovascular age-related macular degeneration (nAMD)
- Diabetic macular edema (DME)
- Neovascular age-related macular degeneration (nAMD)
- Diabetic macular edema (DME)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor