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To study the the Efficacy and Safety of Intravitreal Injection of DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

A Phase III, Multicenter, Sham-Controlled, Randomized, Double- Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 µg DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye. - LUMINA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024680
Enrollment
200
Registered
2020-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H30- Chorioretinal inflammation

Interventions

Intervention1: Sirolimus - 440 µg of DE-109 Injectable Solution: Test Arm: Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4) (approximately 80 su

Sponsors

Santen Incorporated
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Non-Infectious Active Uveitis of the Posterior Segment

Exclusion criteria

Exclusion criteria: Females who are pregnant, nursing or planning a pregnancy. Confirmed or suspected infectious uveitis.

Design outcomes

Primary

MeasureTime frame
Vitreous Haze of zero responseTimepoint: Month 3—

Secondary

MeasureTime frame
Vitreous Haze of zero or 0.5 plus responseTimepoint: Month 3 and 5—

Countries

Argentina, India, Italy

Contacts

Public ContactVikrant Pratap Singh

Excel Life Sciences Pvt. Ltd.

vikrant.singh@avacare.com09650207068

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026