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

Non Infectious Uveitis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03711929
• Other study ID #: 010906IN
• Status: Terminated
• Phase: Phase 3
• Start date: November 19, 2018
• Est. completion date: June 14, 2022

Study information

• Verified date: November 2023
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 145
• Est. completion date: June 14, 2022
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non Infectious Uveitis
• Uveitis

Intervention

Drug:
• DE-109 Intravitreal Injections
440 ug of DE-109 Injectable Solution

Other:
• Sham Procedure
The sham procedure mimics an intravitreal injection without penetrating the eye.

Drug:
• 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)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Countries where clinical trial is conducted

United States,  Argentina,  India,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitreous Haze (VH) of Zero Response at Month 5	Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows: Score = 0: No inflammation; Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex); Score = 1+: Mild blurring of the retinal vessels and optic nerve; Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+; Score = 2+: Moderate blurring of the optic nerve head; Score = 3+: Marked blurring of the optic nerve head; Score = 4+: Optic nerve head not visible; VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale.; The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 5	Month 5
Secondary	Mean Composite Score at Month 3 and Month 5	Composite score scale is defined as follows. Each study eye was assigned one of the following scores: Score = 3 if a study eye achieved Vitreous Haze (VH) score of 0 at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.; Score = 2 if a study eye had at least improved (decreased) by 2 units (i.e., 2+ to 0, 3+ to 1+, or 4+ to 2+) in VH (compared to baseline) at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.; Score = 1 if a study eye achieved VH score of 0.5+ at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.; Score = -1 if a study eye got rescued due to worsening of uveitis or discontinued from the study due to lack of efficacy or due to adverse event prior to the specified visit.; Score = 0 if otherwise	Month 3, Month 5
Secondary	Vitreous Haze (VH) of Zero Response at Month 3	Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows: Score = 0: No inflammation; Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex); Score = 1+: Mild blurring of the retinal vessels and optic nerve; Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+; Score = 2+: Moderate blurring of the optic nerve head; Score = 3+: Marked blurring of the optic nerve head; Score = 4+: Optic nerve head not visible; VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale.; The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 3.	Month 3