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Monoclonal Antibodies

Tocilizumab (8 mg/kg) for Intermediate Uveitis (STOP-Uveitis Trial)

Phase 1 & 2
Waitlist Available
Led By Quan D Nguyen, MD, MSc
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 3, 6, and 12 after therapy or at the time of rescue therapy administration.
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial is testing the safety and effectiveness of Tocilizumab, given in two different doses, for patients with certain types of non-infectious eye inflammation. The medication aims to reduce inflammation by blocking a protein that causes it. Tocilizumab has been studied extensively for its efficacy in treating various refractory ocular inflammatory diseases, including uveitis and macular edema.

Eligible Conditions
  • Intermediate Uveitis
  • Panuveitis
  • Chorioretinitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 3, 6, and 12 after therapy or at the time of rescue therapy administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 3, 6, and 12 after therapy or at the time of rescue therapy administration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency and severity of adverse events from baseline (BL) to month 6.
Secondary study objectives
Frequency and severity of adverse events at month 12.
Other study objectives
Percentage of patients with a decrease of ≥ 2 steps in vitreous haze or resolution of haze (for patients with 1+ haze at baseline) based on the National Eye Institute (NEI) scale at 1, 3, 6, and 12 months after therapy or at time of rescue.

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474
11%
Low ANC
5%
nausea
5%
agranulocytosis
5%
Inpatient admission
5%
fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tocilizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tocilizumab (8 mg/kg)Experimental Treatment1 Intervention
Tocilizumab (8 mg/kg) as an intravenous infusion over 1 hour at day 0, 30, 60, 90, 120, and 150.
Group II: Tocilizumab (4 mg/kg)Experimental Treatment1 Intervention
Tocilizumab (4 mg/kg) as an intravenous infusion over 1 hour at day 0, 30, 60, 90, 120, and 150.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
FDA approved

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,349 Total Patients Enrolled
Quan D Nguyen, MD, MScPrincipal InvestigatorTruhlsen Eye Institute, University of Nebraska Medical Center
8 Previous Clinical Trials
332 Total Patients Enrolled
~3 spots leftby Dec 2025
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