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
Public ClinicalTrials.gov record NCT03711929. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03711929
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 145 participants
Conditions and interventions
Conditions
Interventions
- DE-109 Intravitreal Injections Drug
- Sham Procedure Other
- DE-109 Intravitreal Injections (Open Label) Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 19, 2018 (Actual)
- Primary completion
- Jun 14, 2022 (Actual)
- Completion
- Jun 14, 2022 (Actual)
- Last update posted
- Dec 4, 2023
2018 – 2022
United States locations
- U.S. sites
- 38
- U.S. states
- 22
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Retina & Vitreous Consultants | Phoenix | Arizona | 85021 | — |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | — |
| Kaiser Permanente Medical Center | Los Angeles | California | 90027 | — |
| USC Roski Eye Institute | Los Angeles | California | 90032 | — |
| Byers Eye Institute at Stanford | Palo Alto | California | 94303 | — |
| California Eye Specialist Medical Group, Inc. | Pasadena | California | 91107 | — |
| Colorado Retina Associates | Golden | Colorado | 80401 | — |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | — |
| University of South Florida Eye Institute | Tampa | Florida | 33612 | — |
| Emory Eye Center | Atlanta | Georgia | 30322 | — |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | — |
| Cook County Health & Hospitals System | Chicago | Illinois | 60612 | — |
| Illinois Retina Associate | Oak Park | Illinois | 60304 | — |
| Raj K.Maturi, MD | Indianapolis | Indiana | 46290 | — |
| University of Kansas School of Medicine | Prairie Village | Kansas | 66208 | — |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | — |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02673 | — |
| Kresge Eye Institute | Detroit | Michigan | 48201 | — |
| Associated Retina Consultants-Royal Oak | Royal Oak | Michigan | 48073 | — |
| Discover Vision Center | Independence | Missouri | 64055 | — |
| Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | — |
| New York Eye & Ear Infirmary of Mt. Sinai | New York | New York | 10003 | — |
| Wake Forest Baptist Medical Center/Surgery | Winston-Salem | North Carolina | 27157 | — |
| Cleveland Clinic Cole Eye Institute | Cleveland | Ohio | 44195 | — |
| Cascade Medical Research Institute, LLC | Eugene | Oregon | 97401 | — |
| Retina Vitreous Consultants | Monroeville | Pennsylvania | 15146 | — |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | — |
| UPMC Eye Center | Pittsburgh | Pennsylvania | 15213 | — |
| Vanderbilt Eye Institute | Nashville | Tennessee | 37215 | — |
| Austin Retina Associate | Austin | Texas | 78705 | — |
| Texas Retina Associates-Dallas-Main | Dallas | Texas | 75231 | — |
| Houston Eye Associates | Houston | Texas | 77025 | — |
| Retina Consultants of Houston | Houston | Texas | 77030 | — |
| Valley Retina Institute | McAllen | Texas | 78503 | — |
| Foresight Studies, San Antonio | San Antonio | Texas | 78217 | — |
| Medical Center Ophthalmology Associate | San Antonio | Texas | 78240 | — |
| Retina Group of Washington | Fairfax | Virginia | 22031 | — |
| West Virginia University Eye Institute | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03711929, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2023 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03711929 live on ClinicalTrials.gov.