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Immunosuppressant

Intravitreal injection of sirolimus 880mcg for Panuveitis (SAVE-2 Trial)

Phase 2

Waitlist Available

Led By Quan D Nguyen, MD, MSc

Research Sponsored by Stanford University

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 6 months

Awards & highlights

SAVE-2 Trial Summary

This trial is testing the safety and effectiveness of two doses of the drug sirolimus given inside the eye to treat uveitis.

Eligible Conditions

Panuveitis
Intermediate Uveitis
Uveitis
Chorioretinitis

SAVE-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of uveitic attacks as assessed by vitreous haze and cells.

Secondary outcome measures

Changes in central retinal thickness

Incidence of adverse and serious adverse events

Steroid sparing effect

SAVE-2 Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

Intravitreal injections of 880mcg sirolimus (high-dose every other month group)

Group II: Group 1Experimental Treatment1 Intervention

Intravitreal injections of 440mcg sirolimus (low-dose monthly group)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,341,236 Total Patients Enrolled

Santen Inc.Industry Sponsor

34 Previous Clinical Trials

4,569 Total Patients Enrolled

Quan D Nguyen, MD, MScPrincipal InvestigatorStanford University Byers Eye Institute

8 Previous Clinical Trials

368 Total Patients Enrolled

2 Trials studying Panuveitis

66 Patients Enrolled for Panuveitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still able to sign up for this research project?

"Yes, this is an ongoing clinical trial that has updated their recruitment information as recently as May 5th, 2021. They are looking for 30 individuals to participate in 1 location."

Answered by AI

How many people are involved in this experiment?

"That is correct. The listings on clinicaltrials.gov show that this study, which was first advertised on March 1st 2011, is currently looking for patients to enroll. They are hoping to get 30 people to participate at a single site."

Answered by AI

What have been some recent successes of Intravitreal injection of sirolimus 880mcg?

"Sirolimus, when administered through intravitreal injection in a 880mcg concentration, is commonly used to treat rejection following liver transplant. It has also been found to mitigate the effects of other diseases such as renal angiomyolipomas."

Answered by AI

Are there previous instances of Intravitreal injection of sirolimus 880mcg?

"Intravitreal injection of sirolimus 880mcg is being studied in 130 active clinical trials, with 13 of those studies in Phase 3. The majority of these medical trials are taking place in Cincinnati, Ohio; however, there are a total 1084 locations running clinical trials for Intravitreal injection of sirolimus 880mcg across the world."

Answered by AI

Has the FDA granted approval to use 880mcg sirolimus via intravitreal injection?

"Intravitreal injection of sirolimus 880mcg is still being tested for efficacy in clinical trials, but there is some evidence that it is safe. Our team gives it a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravitreal Sirolimus as Therapeutic Approach to Uveitis

Quan Dong Nguyen 2022. "Intravitreal Sirolimus as Therapeutic Approach to Uveitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01280669.