LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Non Infectious Uveitis
In brief
This is a Phase III study to assess the efficacy 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.
Key facts
- Study ID
- NCT03711929
- Run by
- Santen Inc.
- People needed
- 145
- Starts
- 2018-11-19
- Expected to finish
- 2022-06-14
- Last updated by the study team
- 2023-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Non-Infectious Active Uveitis of the Posterior Segment
You may not qualify if…
- Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected infectious uveitis
Where it is running
- Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
- Kaiser Permanente Medical Center — Los Angeles, California, United States
- USC Roski Eye Institute — Los Angeles, California, United States
- Byers Eye Institute at Stanford — Palo Alto, California, United States
- California Eye Specialist Medical Group, Inc. — Pasadena, California, United States
- Colorado Retina Associates — Golden, Colorado, United States
- Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
- University of South Florida Eye Institute — Tampa, Florida, United States
- Emory Eye Center — Atlanta, Georgia, United States
- Marietta Eye Clinic — Marietta, Georgia, United States
- Cook County Health & Hospitals System — Chicago, Illinois, United States
- Illinois Retina Associate — Oak Park, Illinois, United States
- Raj K.Maturi, MD — Indianapolis, Indiana, United States
- University of Kansas School of Medicine — Prairie Village, Kansas, United States
- Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
- Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
- Kresge Eye Institute — Detroit, Michigan, United States
- Associated Retina Consultants-Royal Oak — Royal Oak, Michigan, United States
- Discover Vision Center — Independence, Missouri, United States
- Eye Associates of New Mexico — Albuquerque, New Mexico, United States
- New York Eye & Ear Infirmary of Mt. Sinai — New York, New York, United States
- Wake Forest Baptist Medical Center/Surgery — Winston-Salem, North Carolina, United States
- Cleveland Clinic Cole Eye Institute — Cleveland, Ohio, United States
- Cascade Medical Research Institute, LLC — Eugene, Oregon, United States
- Arizona Retina & Vitreous Consultants — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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