Back to resultsLUMINA 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
Primary Purpose
Non Infectious Uveitis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DE-109 Intravitreal Injections
Sham Procedure
DE-109 Intravitreal Injections
Sponsored by
About this trial
This is an interventional treatment trial for Non Infectious Uveitis
Eligibility 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
Sites / Locations
- Arizona Retina & Vitreous Consultants
- Retina-Vitreous Associates Medical Group
- Kaiser Permanente Medical Center
- USC Roski Eye Institute
- Byers Eye Institute at Stanford
- California Eye Specialist Medical Group, Inc.
- Colorado Retina Associates
- Retina Vitreous Associates of Florida
- University of South Florida Eye Institute
- Emory Eye Center
- Marietta Eye Clinic
- Cook County Health & Hospitals System
- Illinois Retina Associate
- Raj K.Maturi, MD
- University of Kansas School of Medicine
- Cumberland Valley Retina Consultants
- Ophthalmic Consultants of Boston
- Kresge Eye Institute
- Associated Retina Consultants-Royal Oak
- Discover Vision Center
- Eye Associates of New Mexico
- New York Eye & Ear Infirmary of Mt. Sinai
- Wake Forest Baptist Medical Center/Surgery
- Cleveland Clinic Cole Eye Institute
- Cascade Medical Research Institute, LLC
- Retina Vitreous Consultants
- Mid Atlantic Retina
- UPMC Eye Center
- Vanderbilt Eye Institute
- Austin Retina Associate
- Texas Retina Associates-Dallas-Main
- Houston Eye Associates
- Retina Consultants of Houston
- Valley Retina Institute
- Foresight Studies, San Antonio
- Medical Center Ophthalmology Associate
- Retina Group of Washington
- West Virginia University Eye Institute
- Centro De Ojos Loria SRL
- Clinica Privada de Ojos
- Primer Hospital Privado De Ojos
- Hospital Universitario Austral
- Gustavo Ariel Budmann Private Office
- Oftalmologia Global
- Organización Médica de Investigación (OMI)
- Centro Privado de Ojos Romagosa Fundacion VER
- Sri Sankaradeva Nethralaya
- Banker's Retina Clinic & Laser Centre
- Narayana Nethralaya
- Disha Eye Hospitals Pvt Ltd
- PBMA'S H. V. Desai Eye Hospital
- LV Prasad Eye Institute
- SMS Hospital
- Sankara Nethralaya
- Aravind Eye Hospitals
- Aravind Eye Hospital (Coimbatore)
- L V Prasad Eye Institute
- Dr. J.L. Rohatgi Memorial Eye Hospital
- BB Eye Foundation
- Advanced Eye Center
- Polo Universita degli Studi di Milano Ospedale Luigi Sacco Clinca Oculistica (Eye Clinic)
- Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica
- A.O.U. Policlinico SantOrsola-Malpigi
- San Raffaele Scientific Institute
- Azienda USL IRCCS Reggio Emilia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Other
Arm Label
Test Arm: DE-109 Injectable Solution
Control Arm: Sham Procedure
Dummy Arm: DE-109 Injectable Solution
Arm Description
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).
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.
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).
Outcomes
Primary Outcome Measures
Vitreous Haze (VH)
VH of zero response at Month 5
Secondary Outcome Measures
Vitreous Haze (VH)
VH of zero or 2-unit response at Month 3 and 5
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03711929
Brief Title
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
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
June 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Infectious Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Arm: DE-109 Injectable Solution
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Arm: Sham Procedure
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Dummy Arm: DE-109 Injectable Solution
Arm Type
Other
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
DE-109 Intravitreal Injections
Intervention Description
440 ug of DE-109 Injectable Solution
Intervention Type
Other
Intervention Name(s)
Sham Procedure
Intervention Description
The sham procedure mimics an intravitreal injection without penetrating the eye.
Intervention Type
Drug
Intervention Name(s)
DE-109 Intravitreal Injections
Intervention Description
Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
Primary Outcome Measure Information:
Title
Vitreous Haze (VH)
Description
VH of zero response at Month 5
Time Frame
Month 5
Secondary Outcome Measure Information:
Title
Vitreous Haze (VH)
Description
VH of zero or 2-unit response at Month 3 and 5
Time Frame
Month 3, Month 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Arizona Retina & Vitreous Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
USC Roski Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90032
Country
United States
Facility Name
Byers Eye Institute at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
California Eye Specialist Medical Group, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
University of South Florida Eye Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Marietta Eye Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Cook County Health & Hospitals System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Retina Associate
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
Facility Name
Raj K.Maturi, MD
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Kansas School of Medicine
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02673
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Associated Retina Consultants-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Discover Vision Center
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
New York Eye & Ear Infirmary of Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Wake Forest Baptist Medical Center/Surgery
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cascade Medical Research Institute, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Retina Vitreous Consultants
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt Eye Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Austin Retina Associate
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Retina Associates-Dallas-Main
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Foresight Studies, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Medical Center Ophthalmology Associate
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Group of Washington
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
West Virginia University Eye Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Centro De Ojos Loria SRL
City
Lomas De Zamora
State/Province
Buenos Aires
ZIP/Postal Code
B1832IXE
Country
Argentina
Facility Name
Clinica Privada de Ojos
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600DFC
Country
Argentina
Facility Name
Primer Hospital Privado De Ojos
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1033AAW
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1425BGR
Country
Argentina
Facility Name
Gustavo Ariel Budmann Private Office
City
Buenos Aires
State/Province
Odisha
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Oftalmologia Global
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Organización Médica de Investigación (OMI)
City
Caba
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Centro Privado de Ojos Romagosa Fundacion VER
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Sri Sankaradeva Nethralaya
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781028
Country
India
Facility Name
Banker's Retina Clinic & Laser Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380009
Country
India
Facility Name
Narayana Nethralaya
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
Facility Name
Disha Eye Hospitals Pvt Ltd
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411060
Country
India
Facility Name
PBMA'S H. V. Desai Eye Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411060
Country
India
Facility Name
LV Prasad Eye Institute
City
Bhubaneswar
State/Province
Odisha
ZIP/Postal Code
751024
Country
India
Facility Name
SMS Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
Sankara Nethralaya
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600006
Country
India
Facility Name
Aravind Eye Hospitals
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625020
Country
India
Facility Name
Aravind Eye Hospital (Coimbatore)
City
Coimbatore
State/Province
Tamilnadu
ZIP/Postal Code
641014
Country
India
Facility Name
L V Prasad Eye Institute
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Facility Name
Dr. J.L. Rohatgi Memorial Eye Hospital
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208005
Country
India
Facility Name
BB Eye Foundation
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700059
Country
India
Facility Name
Advanced Eye Center
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Polo Universita degli Studi di Milano Ospedale Luigi Sacco Clinca Oculistica (Eye Clinic)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
A.O.U. Policlinico SantOrsola-Malpigi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
San Raffaele Scientific Institute
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda USL IRCCS Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
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
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