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Trial record 2 of 7 for:    santen uveitis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711929
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE November 19, 2018
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
Vitreous Haze (VH) [ Time Frame: Month 3 ]
VH of zero response at Month 3
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03711929 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
Vitreous Haze (VH) [ Time Frame: Month 3, Month 5 ]
VH of zero or 0.5 + response at Month 3 and 5
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non Infectious Uveitis
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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) (approximately 80 subjects).
    Intervention: Drug: DE-109 Intravitreal Injections
  • Sham Comparator: Control Arm: Sham Procedure
    Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4) (approximately 80 subjects). The sham procedure mimics an intravitreal injection without penetrating the eye.
    Intervention: Other: Sham Procedure
  • 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) (approximately 40 subjects). This study arm (which has the same route of administration and frequency as the test arm).
    Intervention: Drug: DE-109 Intravitreal Injections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Santen Inc. Clinical Operations (415)-268-9169 clinicaltrials@santen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03711929
Other Study ID Numbers  ICMJE 010906IN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Santen Inc.
Study Sponsor  ICMJE Santen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Santen Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP