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
NCT ID: NCT03711929
Last Updated: 2023-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
145 participants
INTERVENTIONAL
2018-11-19
2022-06-14
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
DE-109 Intravitreal Injections
440 ug of DE-109 Injectable Solution
Control Arm: Sham Procedure
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
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).
DE-109 Intravitreal Injections
Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
Open-label:DE-109 Injectable Solution
Subjects completing the Month 6 pre-dose evaluations (the final evaluations in the double-masked period) began the open-label period of the study, in which all subjects received intravitreal injection of DE-109 440 μg in the study eye(s) every 2 months for an additional 6 months of dosing.
DE-109 Intravitreal Injections (Open Label)
After double-masked treatment period (injections every 2 months), eligible subjects would enter the open-labeled period and had DE-109 440 ug injections every 2 months (Month 6, Month 8, and Month 10)
Interventions
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DE-109 Intravitreal Injections
440 ug of DE-109 Injectable Solution
Sham Procedure
The sham procedure mimics an intravitreal injection without penetrating the eye.
DE-109 Intravitreal Injections
Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
DE-109 Intravitreal Injections (Open Label)
After double-masked treatment period (injections every 2 months), eligible subjects would enter the open-labeled period and had DE-109 440 ug injections every 2 months (Month 6, Month 8, and Month 10)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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Arizona Retina & Vitreous Consultants
Phoenix, Arizona, United States
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
Retina Vitreous Consultants
Monroeville, Pennsylvania, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Austin Retina Associate
Austin, Texas, United States
Texas Retina Associates-Dallas-Main
Dallas, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Valley Retina Institute
McAllen, Texas, United States
Foresight Studies, San Antonio
San Antonio, Texas, United States
Medical Center Ophthalmology Associate
San Antonio, Texas, United States
Retina Group of Washington
Fairfax, Virginia, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Centro De Ojos Loria SRL
Lomas de Zamora, Buenos Aires, Argentina
Clinica Privada de Ojos
Mar del Plata, Buenos Aires, Argentina
Primer Hospital Privado De Ojos
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Universitario Austral
Buenos Aires, Buenos Aires F.D., Argentina
Gustavo Ariel Budmann Private Office
Buenos Aires, Odisha, Argentina
Oftalmologia Global
Rosario, Santa Fe Province, Argentina
Organización Médica de Investigación (OMI)
Caba, , Argentina
Centro Privado de Ojos Romagosa Fundacion VER
Córdoba, , Argentina
Sri Sankaradeva Nethralaya
Guwahati, Assam, India
Banker's Retina Clinic & Laser Centre
Ahmedabad, Gujarat, India
Narayana Nethralaya
Bangalore, Karnataka, India
Disha Eye Hospitals Pvt Ltd
Pune, Maharashtra, India
PBMA'S H. V. Desai Eye Hospital
Pune, Maharashtra, India
LV Prasad Eye Institute
Bhubaneswar, Odisha, India
SMS Hospital
Jaipur, Rajasthan, India
Sankara Nethralaya
Chennai, Tamil Nadu, India
Aravind Eye Hospital (Coimbatore)
Coimbatore, Tamil Nadu, India
Aravind Eye Hospitals
Madurai, Tamil Nadu, India
L V Prasad Eye Institute
Hyderabad, Telangana, India
Dr. J.L. Rohatgi Memorial Eye Hospital
Kanpur, Uttar Pradesh, India
BB Eye Foundation
Kolkata, West Bengal, India
Advanced Eye Center
Chandigarh, , India
Polo Universita degli Studi di Milano Ospedale Luigi Sacco Clinca Oculistica (Eye Clinic)
Milan, Lombardy, Italy
Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica
Padua, Veneto, Italy
A.O.U. Policlinico SantOrsola-Malpigi
Bologna, , Italy
San Raffaele Scientific Institute
Milan, , Italy
Azienda USL IRCCS Reggio Emilia
Reggio Emilia, , Italy
Countries
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References
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Hashida N, Nishida K. Recent advances and future prospects: Current status and challenges of the intraocular injection of drugs for vitreoretinal diseases. Adv Drug Deliv Rev. 2023 Jul;198:114870. doi: 10.1016/j.addr.2023.114870. Epub 2023 May 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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010906IN
Identifier Type: -
Identifier Source: org_study_id