Clinical trial

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.

NCT03711929

Name

010906IN

Description

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.

Trial arms

Trial start

2018-11-19

Estimated PCD

2022-06-14

Trial end

2022-06-14

Status

Terminated

Phase

Early phase I

Treatment

DE-109 Intravitreal Injections

440 ug of DE-109 Injectable Solution

Arms:

Test Arm: DE-109 Injectable Solution

Sham Procedure

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

Arms:

Control Arm: Sham Procedure

DE-109 Intravitreal Injections

Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)

Arms:

Dummy Arm: DE-109 Injectable Solution

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)

Arms:

Open-label:DE-109 Injectable Solution

Size

145

Primary endpoint

Vitreous Haze (VH) of Zero Response at Month 5

Month 5

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 145, 'type': 'ACTUAL'}}

Updated at

2023-12-04

1 organization

1 product

1 indication

Product

DE-109

Indication

Non-infectious Uveitis

Organization

Santen