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Trial record 2 of 7 for:    santen uveitis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711929
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Non Infectious Uveitis Drug: DE-109 Intravitreal Injections Other: Sham Procedure Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Arm: DE-109 Injectable Solution
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4) (approximately 80 subjects).
Drug: DE-109 Intravitreal Injections
440 ug of DE-109 Injectable Solution

Sham Comparator: Control Arm: Sham Procedure
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4) (approximately 80 subjects). The sham procedure mimics an intravitreal injection without penetrating the eye.
Other: Sham Procedure
The sham procedure mimics an intravitreal injection without penetrating the eye.

Dummy Arm: DE-109 Injectable Solution
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4) (approximately 40 subjects). This study arm (which has the same route of administration and frequency as the test arm).
Drug: DE-109 Intravitreal Injections
Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)




Primary Outcome Measures :
  1. Vitreous Haze (VH) [ Time Frame: Month 3 ]
    VH of zero response at Month 3


Secondary Outcome Measures :
  1. Vitreous Haze (VH) [ Time Frame: Month 3, Month 5 ]
    VH of zero or 0.5 + response at Month 3 and 5



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Non-Infectious Active Uveitis of the Posterior Segment

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711929


Contacts
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Contact: Santen Inc. Clinical Operations (415)-268-9169 clinicaltrials@santen.com

Locations
Hide Hide 60 study locations
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United States, Arizona
Arizona Retina & Vitreous Consultants Recruiting
Phoenix, Arizona, United States, 85021
Global Retina Institute Recruiting
Scottsdale, Arizona, United States, 85254
United States, California
California Retina Consultants Recruiting
Bakersfield, California, United States, 93309
Retina-Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Loma Linda University Eye Institute Recruiting
Loma Linda, California, United States, 92354
USC Roski Eye Institute Recruiting
Los Angeles, California, United States, 90032
Byers Eye Institute at Stanford Recruiting
Palo Alto, California, United States, 94303
California Eye Specialist Medical Group, Inc. Recruiting
Pasadena, California, United States, 91107
West Coast Retina Recruiting
San Francisco, California, United States, 94925
United States, Colorado
Colorado Retina Associates Recruiting
Golden, Colorado, United States, 80401
United States, Connecticut
New England Retina Associates Recruiting
Hamden, Connecticut, United States, 06518
Yale Ophthalmology & Visual Science Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Retina Vitreous Associates of Florida Recruiting
Saint Petersburg, Florida, United States, 33711
University of South Florida Eye Institute Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Emory Eye Center Recruiting
Atlanta, Georgia, United States, 30322
Marietta Eye Clinic Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Cook County Health & Hospitals System Recruiting
Chicago, Illinois, United States, 60612
Illinois Retina Associate Recruiting
Oak Park, Illinois, United States, 60304
Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
United States, Indiana
Raj K.Maturi, MD Recruiting
Indianapolis, Indiana, United States, 46290
United States, Kansas
University of Kansas School of Medicine Recruiting
Prairie Village, Kansas, United States, 66208
United States, Kentucky
Retina Associates of Kentucky Recruiting
Lexington, Kentucky, United States, 40509
United States, Maryland
Wilmer Eye Institute, Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Cumberland Valley Retina Consultants Recruiting
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02673
United States, Michigan
Kresge Eye Institute Recruiting
Detroit, Michigan, United States, 48201
Associated Retina Consultants-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic - Rochester Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Discover Vision Center Recruiting
Independence, Missouri, United States, 64055
Washington University in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63108
United States, New Jersey
Metropolitan Eye Research & Surgery Institute Recruiting
Palisades Park, New Jersey, United States, 07650
United States, New Mexico
Eye Associates of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
New York Eye & Ear Infirmary of Mt. Sinai Recruiting
New York, New York, United States, 10003
MaculaCare PLLC Recruiting
New York, New York, United States, 10021
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27705
Wake Forest Baptist Medical Center/Surgery Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Retina Associate of Cleveland Recruiting
Beachwood, Ohio, United States, 44122
Cleveland Clinic Cole Eye Institute Recruiting
Cleveland, Ohio, United States, 44195
United States, Oregon
Cascade Medical Research Institute, LLC Recruiting
Eugene, Oregon, United States, 97401
Legacy Devers Eye Institute Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Retina Vitreous Consultants Recruiting
Monroeville, Pennsylvania, United States, 15146
Mid Atlantic Retina Recruiting
Philadelphia, Pennsylvania, United States, 19107
UPMC Eye Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Palmetto Retina Center Recruiting
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Vanderbilt Eye Institute Recruiting
Nashville, Tennessee, United States, 37215
United States, Texas
Texas Retina Associates, Arlington Recruiting
Arlington, Texas, United States, 76012
Austin Retina Associate Recruiting
Austin, Texas, United States, 78705
Texas Retina Associates-Dallas-Main Recruiting
Dallas, Texas, United States, 75231
Houston Eye Associates Recruiting
Houston, Texas, United States, 77025
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Valley Retina Institute Recruiting
McAllen, Texas, United States, 78503
Foresight Studies, San Antonio Recruiting
San Antonio, Texas, United States, 78217
Medical Center Ophthalmology Associate Recruiting
San Antonio, Texas, United States, 78240
Retina Consultants of Houston Recruiting
The Woodlands, Texas, United States, 77384
United States, Virginia
Retina Group of Washington Recruiting
Fairfax, Virginia, United States, 22031
United States, West Virginia
West Virginia University Eye Institute Recruiting
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Santen Inc.

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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT03711929    
Other Study ID Numbers: 010906IN
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases
Pharmaceutical Solutions