Safety and Efficacy of DE-109 injection in patients with active, non-infectious inflammation of middle layer of the eye

A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study Assessing the Safety and Efficacy of Intravitreal Injectio ns of DE-109 (three doses) for the Treatment of active, Non-Infectious Uveitis of the Posterior Segment of the eye - The SAKURA Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/12/002309

Enrollment

600

Registered

2011-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Active, Non-Infectious Uveitis of the Posterior Segment of the eye Health Condition 2: H208- Other iridocyclitis

Interventions

Intervention1: DE-109 Injectable solution: Low Dose (44 &#956

g)- 0.2% w/w sirolimus, 2.2 &#956

g/&#956

L Medium Dose (440 &#956

g) - 2.0% w/w sirolimus, 22 &#956

L High Dose (880 &#956

g)- 4.0% w/w sirolimus, 44 &#956

L Intervention2: DE-109: Nature of Intervention: Active Dose: 44mg (3 injections every 2 months at Day 1, 60 and 120) Frequency: Every two months for a total of three doses (Day 1, 60 & 120) Duration:

g) Medium Dose (440 &#956

g) High Dose (880 &#956

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ability to give informed consent and attend all study visits 2. Males or females greater than or equal to 18 years of age 3. Have diagnosis of active uveitis determined by the Investigator to be non-infectious based on the subject?s medical history, history of present illness, ocular examination, review of systems, physical examination, and any relevant, pertinent laboratory evaluations. If an anterior component is present, it must be less than the posterior component 4. Have active uveitis defined as having 1+ (excluding 1+) vitreous haze score (SUN scale) 5. Best-corrected ETDRS visual acuity letter score of 19 letters or more (20/400 Snellen equivalent) or better in study eye

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Proportion of subjects with a vitreous haze score of 0 at Month 5 (Standardized Uveitis Nomenclature [SUN]Photographic scale)Timepoint: Month 5	—

Secondary

Measure	Time frame
Proportion of subjects with a 2 unit improvement in vitreous haze score at Month 5 Time to achieve a vitreous haze score of 0 Mean change from Baseline in vitreous haze score at Month 5 Proportion of subjects on 5 mg/day of prednisone at Month 5 Mean change from Baseline in ETDRS BCVA at Month 5 Mean change from Baseline in central foveal thickness at Month 5 Change from Baseline in the National Eye Institute (NEI) Visual Functioning Questionnaire-25 (VFQ-25)Timepoint: Month 5 (Day 150)	—

Measure

Time frame

Proportion of subjects with a 2 unit improvement in vitreous haze score at Month 5 Time to achieve a vitreous haze score of 0 Mean change from Baseline in vitreous haze score at Month 5 Proportion of subjects on 5 mg/day of prednisone at Month 5 Mean change from Baseline in ETDRS BCVA at Month 5 Mean change from Baseline in central foveal thickness at Month 5 Change from Baseline in the National Eye Institute (NEI) Visual Functioning Questionnaire-25 (VFQ-25)Timepoint: Month 5 (Day 150)

—

Countries

Argentina, Austria, Brazil, Chile, Colombia, Czech Republic, Dominican Republic, France, Germany, India, Israel, Italy, Netherlands, Peru, Poland, Spain, Turkey, United Kingdom, United States of America

Contacts

Public ContactDr Saurendra Das

Excel Life Sciences

sauren@excellifesciences.com0120-4022601

Outcome results

None listed

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