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

NCT03711929 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 010906IN
• Study Type: interventional
• Target: 145
• Locations: 4 countries
• Sites: 65

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.

Conditions

Non Infectious Uveitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean Composite Score at Month 3 and Month 5

  Month 3, Month 5

• Vitreous Haze (VH) of Zero Response at Month 3

  Month 3

Study Arms (4)

Test Arm: DE-109 Injectable Solution

EXPERIMENTAL

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

Control Arm: Sham Procedure

SHAM COMPARATOR

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

Dummy Arm: DE-109 Injectable Solution

OTHER

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

Open-label:DE-109 Injectable Solution

EXPERIMENTAL

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)

Interventions

DE-109 Intravitreal Injections DRUG

440 ug of DE-109 Injectable Solution

Test Arm: DE-109 Injectable Solution

Sham Procedure OTHER

The sham procedure mimics an intravitreal injection without penetrating the eye.

Control Arm: Sham Procedure

DE-109 Intravitreal Injections (Open Label) DRUG

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)

Open-label:DE-109 Injectable Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Infectious Active Uveitis of the Posterior Segment

You may not qualify if:

• Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected infectious uveitis

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (65)

Arizona Retina & Vitreous Consultants

Phoenix, Arizona, 85021, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Kaiser Permanente Medical Center

Los Angeles, California, 90027, United States

Location

USC Roski Eye Institute

Los Angeles, California, 90032, United States

Location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

California Eye Specialist Medical Group, Inc.

Pasadena, California, 91107, United States

Location

Colorado Retina Associates

Golden, Colorado, 80401, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

University of South Florida Eye Institute

Tampa, Florida, 33612, United States

Location

Emory Eye Center

Atlanta, Georgia, 30322, United States

Location

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

Location

Cook County Health & Hospitals System

Chicago, Illinois, 60612, United States

Location

Illinois Retina Associate

Oak Park, Illinois, 60304, United States

Location

Raj K.Maturi, MD

Indianapolis, Indiana, 46290, United States

Location

University of Kansas School of Medicine

Prairie Village, Kansas, 66208, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02673, United States

Location

Kresge Eye Institute

Detroit, Michigan, 48201, United States

Location

Associated Retina Consultants-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Discover Vision Center

Independence, Missouri, 64055, United States

Location

Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

New York Eye & Ear Infirmary of Mt. Sinai

New York, New York, 10003, United States

Location

Wake Forest Baptist Medical Center/Surgery

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

Cascade Medical Research Institute, LLC

Eugene, Oregon, 97401, United States

Location

Retina Vitreous Consultants

Monroeville, Pennsylvania, 15146, United States

Location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Eye Institute

Nashville, Tennessee, 37215, United States

Location

Austin Retina Associate

Austin, Texas, 78705, United States

Location

Texas Retina Associates-Dallas-Main

Dallas, Texas, 75231, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Foresight Studies, San Antonio

San Antonio, Texas, 78217, United States

Location

Medical Center Ophthalmology Associate

San Antonio, Texas, 78240, United States

Location

Retina Group of Washington

Fairfax, Virginia, 22031, United States

Location

West Virginia University Eye Institute

Morgantown, West Virginia, 26506, United States

Location

Centro De Ojos Loria SRL

Lomas de Zamora, Buenos Aires, B1832IXE, Argentina

Location

Clinica Privada de Ojos

Mar del Plata, Buenos Aires, B7600DFC, Argentina

Location

Primer Hospital Privado De Ojos

Buenos Aires, Buenos Aires F.D., C1033AAW, Argentina

Location

Hospital Universitario Austral

Buenos Aires, Buenos Aires F.D., C1425BGR, Argentina

Location

Gustavo Ariel Budmann Private Office

Buenos Aires, Odisha, 1426, Argentina

Location

Oftalmologia Global

Rosario, Santa Fe Province, 2000, Argentina

Location

Organización Médica de Investigación (OMI)

Caba, C1015ABO, Argentina

Location

Centro Privado de Ojos Romagosa Fundacion VER

Córdoba, 5000, Argentina

Location

Sri Sankaradeva Nethralaya

Guwahati, Assam, 781028, India

Location

Banker's Retina Clinic & Laser Centre

Ahmedabad, Gujarat, 380009, India

Location

Narayana Nethralaya

Bangalore, Karnataka, 560010, India

Location

Disha Eye Hospitals Pvt Ltd

Pune, Maharashtra, 411060, India

Location

PBMA'S H. V. Desai Eye Hospital

Pune, Maharashtra, 411060, India

Location

LV Prasad Eye Institute

Bhubaneswar, Odisha, 751024, India

Location

SMS Hospital

Jaipur, Rajasthan, 302004, India

Location

Sankara Nethralaya

Chennai, Tamil Nadu, 600006, India

Location

Aravind Eye Hospital (Coimbatore)

Coimbatore, Tamil Nadu, 641014, India

Location

Aravind Eye Hospitals

Madurai, Tamil Nadu, 625020, India

Location

L V Prasad Eye Institute

Hyderabad, Telangana, 500034, India

Location

Dr. J.L. Rohatgi Memorial Eye Hospital

Kanpur, Uttar Pradesh, 208005, India

Location

BB Eye Foundation

Kolkata, West Bengal, 700059, India

Location

Advanced Eye Center

Chandigarh, 160012, India

Location

Polo Universita degli Studi di Milano Ospedale Luigi Sacco Clinca Oculistica (Eye Clinic)

Milan, Lombardy, 20157, Italy

Location

Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica

Padua, Veneto, 35128, Italy

Location

A.O.U. Policlinico SantOrsola-Malpigi

Bologna, 40138, Italy

Location

San Raffaele Scientific Institute

Milan, 20122, Italy

Location

Azienda USL IRCCS Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Related Publications (1)

• 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.

  PMID: 37172783 DERIVED

Results Point of Contact

• Title: Director of R&D Quality Management
• Organization: Santen Inc

evelyn.chikere@santen.com

15106851794

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: November 19, 2018
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: December 4, 2023
• Results First Posted: December 4, 2023

Record last verified: 2023-11

Locations

US (38); AR (8); IN (14); IT (5)