MedTrace Logo

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 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-12-04

Study results available
· View outcomes & findings →

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

Interventions

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)

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)

Sponsors & Collaborators

  • Santen Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2022-06-14
Completion
2022-06-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • India
  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03711929 on ClinicalTrials.gov