A Study to Assess the Effectiveness and Safety of Intravitreal 440 ug DE-109 Sirolimus Injections for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Overview

About this study

The purpose of this study is to assess the effectiveness and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS). There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Non-Infectious Active Uveitis of the posterior segment of the eye.

Exclusion Criteria:

  • Females who are pregnant, nursing, or planning a pregnancy.
  • Confirmed or suspected infectious uveitis.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Michael Stewart, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20461645

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