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
- Conditions
- Non Infectious Uveitis
- Interventions
- Drug: DE-109 Intravitreal Injections (Open Label)Drug: DE-109 Intravitreal InjectionsOther: Sham Procedure
- Registration Number
- NCT03711929
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 145
Non-Infectious Active Uveitis of the Posterior Segment
Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected infectious uveitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open-label:DE-109 Injectable Solution DE-109 Intravitreal Injections (Open Label) 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. Test Arm: DE-109 Injectable Solution DE-109 Intravitreal Injections Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). Control Arm: Sham Procedure 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. Dummy Arm: DE-109 Injectable Solution DE-109 Intravitreal Injections 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).
- Primary Outcome Measures
Name Time Method Vitreous Haze (VH) of Zero Response at Month 5 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
- Secondary Outcome Measures
Name Time Method Mean Composite Score at Month 3 and Month 5 Month 3, 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 otherwiseVitreous Haze (VH) of Zero Response at Month 3 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.
Trial Locations
- Locations (65)
Kaiser Permanente Medical Center
🇺🇸Los Angeles, California, United States
Emory Eye Center
🇺🇸Atlanta, Georgia, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Raj K.Maturi, MD
🇺🇸Indianapolis, Indiana, United States
Cook County Health & Hospitals System
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
UPMC Eye Center
🇺🇸Pittsburgh, Pennsylvania, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Retina Consultants of Houston
🇺🇸Houston, Texas, United States
Centro Privado de Ojos Romagosa Fundacion VER
🇦🇷Cordoba, Argentina
Narayana Nethralaya
🇮🇳Bangalore, Karnataka, India
Sankara Nethralaya
🇮🇳Chennai, Tamil Nadu, India
Aravind Eye Hospitals
🇮🇳Madurai, Tamil Nadu, India
University of Kansas School of Medicine
🇺🇸Prairie Village, Kansas, United States
Aravind Eye Hospital (Coimbatore)
🇮🇳Coimbatore, Tamilnadu, India
Disha Eye Hospitals Pvt Ltd
🇮🇳Pune, Maharashtra, India
Centro De Ojos Loria SRL
🇦🇷Lomas De Zamora, Buenos Aires, Argentina
L V Prasad Eye Institute
🇮🇳Hyderabad, Telangana, India
Sri Sankaradeva Nethralaya
🇮🇳Guwahati, Assam, India
USC Roski Eye Institute
🇺🇸Los Angeles, California, United States
Byers Eye Institute at Stanford
🇺🇸Palo Alto, California, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Marietta Eye Clinic
🇺🇸Marietta, Georgia, United States
Colorado Retina Associates
🇺🇸Golden, Colorado, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Associated Retina Consultants-Royal Oak
🇺🇸Royal Oak, Michigan, United States
Discover Vision Center
🇺🇸Independence, Missouri, United States
New York Eye & Ear Infirmary of Mt. Sinai
🇺🇸New York, New York, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Cascade Medical Research Institute, LLC
🇺🇸Eugene, Oregon, United States
Retina Vitreous Consultants
🇺🇸Monroeville, Pennsylvania, United States
Texas Retina Associates-Dallas-Main
🇺🇸Dallas, Texas, United States
West Virginia University Eye Institute
🇺🇸Morgantown, West Virginia, United States
Retina Group of Washington
🇺🇸Fairfax, Virginia, United States
Clinica Privada de Ojos
🇦🇷Mar Del Plata, Buenos Aires, Argentina
Primer Hospital Privado De Ojos
🇦🇷Buenos Aires, Caba, Argentina
Oftalmologia Global
🇦🇷Rosario, Santa Fe, Argentina
Gustavo Ariel Budmann Private Office
🇦🇷Buenos Aires, Odisha, Argentina
Organización Médica de Investigación (OMI)
🇦🇷Caba, Argentina
Banker's Retina Clinic & Laser Centre
🇮🇳Ahmedabad, Gujarat, India
PBMA'S H. V. Desai Eye Hospital
🇮🇳Pune, Maharashtra, India
LV Prasad Eye Institute
🇮🇳Bhubaneswar, Odisha, India
SMS Hospital
🇮🇳Jaipur, Rajasthan, India
Dr. J.L. Rohatgi Memorial Eye Hospital
🇮🇳Kanpur, Uttar Pradesh, India
BB Eye Foundation
🇮🇳Kolkata, West Bengal, India
A.O.U. Policlinico SantOrsola-Malpigi
🇮🇹Bologna, Italy
Polo Universita degli Studi di Milano Ospedale Luigi Sacco Clinca Oculistica (Eye Clinic)
🇮🇹Milan, Lombardia, Italy
Advanced Eye Center
🇮🇳Chandigarh, India
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, Italy
California Eye Specialist Medical Group, Inc.
🇺🇸Pasadena, California, United States
Illinois Retina Associate
🇺🇸Oak Park, Illinois, United States
Valley Retina Institute
🇺🇸McAllen, Texas, United States
Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Hospital Universitario Austral
🇦🇷Buenos Aires, Caba, Argentina
Arizona Retina & Vitreous Consultants
🇺🇸Phoenix, Arizona, United States
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States
Wake Forest Baptist Medical Center/Surgery
🇺🇸Winston-Salem, North Carolina, United States
Vanderbilt Eye Institute
🇺🇸Nashville, Tennessee, United States
University of South Florida Eye Institute
🇺🇸Tampa, Florida, United States
Foresight Studies, San Antonio
🇺🇸San Antonio, Texas, United States
Medical Center Ophthalmology Associate
🇺🇸San Antonio, Texas, United States
Austin Retina Associate
🇺🇸Austin, Texas, United States