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Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy

NCT06191094 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Faricimab Injection

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.

DRUG

sham 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 & Collaborators

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-12
Primary Completion
2025-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06191094 on ClinicalTrials.gov