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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Non Infectious Uveitis
• Intervention / Treatment: Drug: DE-109 Intravitreal Injections; Drug: DE-109 Intravitreal Injections; Other: Sham Procedure; Drug: DE-109 Intravitreal Injections (Open Label)

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1015ABO
    • Organizacion Medica de Investigacion (OMI)
  • Cordoba, Argentina, 5000
    • Centro Privado de Ojos Romagosa Fundacion VER
  • Buenos Aires
    • Lomas De Zamora, Buenos Aires, Argentina, B1832IXE
      • Centro De Ojos Loria SRL
    • Mar Del Plata, Buenos Aires, Argentina, B7600DFC
      • Clinica Privada de Ojos
  • Caba
    • Buenos Aires, Caba, Argentina, C1033AAW
      • Primer Hospital Privado De Ojos
    • Buenos Aires, Caba, Argentina, C1425BGR
      • Hospital Universitario Austral
  • Odisha
    • Buenos Aires, Odisha, Argentina, 1426
      • Gustavo Ariel Budmann Private Office
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Oftalmologia Global
• India
  • Chandigarh, India, 160012
    • Advanced Eye Center
  • Assam
    • Guwahati, Assam, India, 781028
      • Sri Sankaradeva Nethralaya
  • Gujarat
    • Ahmedabad, Gujarat, India, 380009
      • Banker's Retina Clinic & Laser Centre
  • Karnataka
    • Bangalore, Karnataka, India, 560010
      • Narayana Nethralaya
  • Maharashtra
    • Pune, Maharashtra, India, 411060
      • PBMA'S H. V. Desai Eye Hospital
    • Pune, Maharashtra, India, 411060
      • Disha Eye Hospitals Pvt Ltd
  • Odisha
    • Bhubaneswar, Odisha, India, 751024
      • LV Prasad Eye Institute
  • Rajasthan
    • Jaipur, Rajasthan, India, 302004
      • SMS Hospital
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600006
      • Sankara Nethralaya
    • Madurai, Tamil Nadu, India, 625020
      • Aravind Eye Hospitals
  • Tamilnadu
    • Coimbatore, Tamilnadu, India, 641014
      • Aravind Eye Hospital (Coimbatore)
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • L V Prasad Eye Institute
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208005
      • Dr. J.L. Rohatgi Memorial Eye Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700059
      • BB Eye Foundation
• Italy
  • Bologna, Italy, 40138
    • A.O.U. Policlinico SantOrsola-Malpigi
  • Milano, Italy, 20122
    • San Raffaele Scientific Institute
  • Reggio Emilia, Italy, 42123
    • Azienda USL IRCCS Reggio Emilia
  • Lombardia
    • Milan, Lombardia, Italy, 20157
      • Polo Universita degli Studi di Milano Ospedale Luigi Sacco Clinca Oculistica (Eye Clinic)
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85021
      • Arizona Retina & Vitreous Consultants
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Medical Center
    • Los Angeles, California, United States, 90032
      • USC Roski Eye Institute
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute at Stanford
    • Pasadena, California, United States, 91107
      • California Eye Specialist Medical Group, Inc.
  • Colorado
    • Golden, Colorado, United States, 80401
      • Colorado Retina Associates
  • Florida
    • Saint Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida Eye Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Eye Center
    • Marietta, Georgia, United States, 30060
      • Marietta Eye Clinic
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Cook County Health & Hospitals System
    • Oak Park, Illinois, United States, 60304
      • Illinois Retina Associate
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj K.Maturi, MD
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • University of Kansas School of Medicine
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants
  • Massachusetts
    • Boston, Massachusetts, United States, 02673
      • Ophthalmic Consultants of Boston
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Kresge Eye Institute
    • Royal Oak, Michigan, United States, 48073
      • Associated Retina Consultants-Royal Oak
  • Missouri
    • Independence, Missouri, United States, 64055
      • Discover Vision Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Eye Associates of New Mexico
  • New York
    • New York, New York, United States, 10003
      • New York Eye & Ear Infirmary of Mt. Sinai
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center/Surgery
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Cole Eye Institute
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Cascade Medical Research Institute, LLC
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • Retina Vitreous Consultants
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Eye Center
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Vanderbilt Eye Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associate
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates-Dallas-Main
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute
    • San Antonio, Texas, United States, 78217
      • Foresight Studies, San Antonio
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associate
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Retina Group of Washington
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: DE-109 Intravitreal Injections; 440 ug of DE-109 Injectable Solution; Drug: DE-109 Intravitreal Injections; Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
Sham Comparator: 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.	Other: Sham Procedure; The sham procedure mimics an intravitreal injection without penetrating the eye.
Other: 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).	Drug: DE-109 Intravitreal Injections; 440 ug of DE-109 Injectable Solution; Drug: DE-109 Intravitreal Injections; Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
Experimental: 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.	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): June 14, 2022

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: 010906IN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No