Clinical trial NCT03711929: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non Infectious Uveitis
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Vitreous Haze (VH) of Zero Response at Month 5
timeFrame: Month 5
Secondary outcomes:
measure: Mean Composite Score at Month 3 and Month 5
timeFrame: Month 3, Month 5
measure: Vitreous Haze (VH) of Zero Response at Month 3
timeFrame: Month 3
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Retina & Vitreous Consultants
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Los Angeles
country: United States
facility: USC Roski Eye Institute
state: California
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford
state: California
city: Pasadena
country: United States
facility: California Eye Specialist Medical Group, Inc.
state: California
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida Eye Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Chicago
country: United States
facility: Cook County Health & Hospitals System
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associate
state: Illinois
city: Indianapolis
country: United States
facility: Raj K.Maturi, MD
state: Indiana
city: Prairie Village
country: United States
facility: University of Kansas School of Medicine
state: Kansas
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retina Consultants-Royal Oak
state: Michigan
city: Independence
country: United States
facility: Discover Vision Center
state: Missouri
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: New York
country: United States
facility: New York Eye & Ear Infirmary of Mt. Sinai
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center/Surgery
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Cole Eye Institute
state: Ohio
city: Eugene
country: United States
facility: Cascade Medical Research Institute, LLC
state: Oregon
city: Monroeville
country: United States
facility: Retina Vitreous Consultants
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Retina Associate
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates-Dallas-Main
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Foresight Studies, San Antonio
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associate
state: Texas
city: Fairfax
country: United States
facility: Retina Group of Washington
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West Virginia
city: Lomas De Zamora
country: Argentina
facility: Centro De Ojos Loria SRL
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Clinica Privada de Ojos
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Primer Hospital Privado De Ojos
state: Caba
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Austral
state: Caba
city: Buenos Aires
country: Argentina
facility: Gustavo Ariel Budmann Private Office
state: Odisha
city: Rosario
country: Argentina
facility: Oftalmologia Global
state: Santa Fe
city: Caba
country: Argentina
facility: Organización Médica de Investigación (OMI)
city: Cordoba
country: Argentina
facility: Centro Privado de Ojos Romagosa Fundacion VER
city: Guwahati
country: India
facility: Sri Sankaradeva Nethralaya
state: Assam
city: Ahmedabad
country: India
facility: Banker's Retina Clinic & Laser Centre
state: Gujarat
city: Bangalore
country: India
facility: Narayana Nethralaya
state: Karnataka
city: Pune
country: India
facility: Disha Eye Hospitals Pvt Ltd
state: Maharashtra
city: Pune
country: India
facility: PBMA'S H. V. Desai Eye Hospital
state: Maharashtra
city: Bhubaneswar
country: India
facility: LV Prasad Eye Institute
state: Odisha
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Chennai
country: India
facility: Sankara Nethralaya
state: Tamil Nadu
city: Madurai
country: India
facility: Aravind Eye Hospitals
state: Tamil Nadu
city: Coimbatore
country: India
facility: Aravind Eye Hospital (Coimbatore)
state: Tamilnadu
city: Hyderabad
country: India
facility: L V Prasad Eye Institute
state: Telangana
city: Kanpur
country: India
facility: Dr. J.L. Rohatgi Memorial Eye Hospital
state: Uttar Pradesh
city: Kolkata
country: India
facility: BB Eye Foundation
state: West Bengal
city: Chandigarh
country: India
facility: Advanced Eye Center
city: Milan
country: Italy
facility: Polo Universita degli Studi di Milano Ospedale Luigi Sacco Clinca Oculistica (Eye Clinic)
state: Lombardia
city: Padova
country: Italy
facility: Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica
state: Veneto
city: Bologna
country: Italy
facility: A.O.U. Policlinico SantOrsola-Malpigi
city: Milano
country: Italy
facility: San Raffaele Scientific Institute
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS Reggio Emilia
Study officials:
References: