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Study Assessing Double-masked Uveitis Treatment

A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01358266
Acronym
SAKURA
Enrollment
592
Registered
2011-05-23
Start date
2011-05-31
Completion date
2016-12-31
Last updated
2019-07-16

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

Conditions

Uveitis; Posterior, Disorder

Brief summary

The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

Interventions

DRUGDE-109 44 ug

Low dose

DRUGDE-109 440 ug

Medium dose

DRUGDE-109 880 ug

High dose

Sponsors

Santen Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Confirmed diagnosis of active uveitis * 18 years of age or older * Sign informed consent * Meet best corrected ETDRS visual acuity

Exclusion criteria

* Uveitis of infectious etiology * Suspected/confirmed central nervous system or ocular lymphoma * Primary diagnosis of anterior uveitis * Uncontrolled glaucoma * Use of topical oculary medication * Implanted device * Significant ocular disease * Lens/media opacities or obscured ocular media * Intraocular surgery or treatments * Capsulotomy * Ocular or periocular infection * Pupillary dilation * History of herpetic infection * Toxoplasmosis or toxoplasmosis scar * Ocular malignancy * Allergy or hypersensitivity to study drug * Participation in other uveitis trial within 30 days * Monoclonal antibody treatment or biologic therapy * Any systemic condition/infection * Immunosuppressive therapy or immunocompromised * Malignancy remission * Females who are pregnant or lactating and females not using adequate contraceptives

Design outcomes

Primary

MeasureTime frameDescription
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5Day1 (Baseline) and Month 5 (Day150)At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation

Secondary

MeasureTime frameDescription
VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)Day1/Baseline and Day150/Month 5At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible
VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)Day1/Baseline and Day150/Month 5At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)

Other

MeasureTime frameDescription
VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)Day1/Baseline and Day180/Month 6At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation
VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)Day1/Baseline and Day180/Month 6At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible
VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)Day1/Baseline and Day180/Month 6At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible

Countries

Argentina, Austria, Brazil, Chile, Colombia, France, Germany, India, Israel, Italy, Japan, Peru, Poland, Spain, Turkey (Türkiye), United Kingdom, United States

Participant flow

Pre-assignment details

Subjects who entered open-label period are defined as subjects who received at least one open-label injection during the open-label treatment period (Month 6 to Month 12, exclude Amendment 2 subjects), or those who had entered the open-label retreatment period (Month 12 to Month 24) with or without any PRN injections.

Participants by arm

ArmCount
DE-109 44 µg
Double Masked Phase Low Dose 44 µg Open Label Phase High Dose 880 µg
208
DE-109 440 µg
Double Masked Phase Medium Dose 440 µg Open Label Phase High Dose 880 µg
208
DE-109 880 µg
Double Masked Phase High Dose 880 µg Open Label Phase High Dose 880 µg
176
Total592

Baseline characteristics

CharacteristicDE-109 44 µgDE-109 440 µgDE-109 880 µgTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
20 Participants17 Participants23 Participants60 Participants
Age, Categorical
Between 18 and 65 years
188 Participants191 Participants153 Participants532 Participants
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants1 Participants3 Participants8 Participants
Race (NIH/OMB)
Asian
76 Participants77 Participants72 Participants225 Participants
Race (NIH/OMB)
Black or African American
16 Participants13 Participants13 Participants42 Participants
Race (NIH/OMB)
More than one race
8 Participants7 Participants3 Participants18 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants10 Participants6 Participants26 Participants
Race (NIH/OMB)
White
93 Participants99 Participants79 Participants271 Participants
Region of Enrollment
Argentina
20 Participants13 Participants10 Participants43 Participants
Region of Enrollment
Austria
3 Participants2 Participants0 Participants5 Participants
Region of Enrollment
Brazil
2 Participants3 Participants5 Participants10 Participants
Region of Enrollment
Chile
3 Participants2 Participants4 Participants9 Participants
Region of Enrollment
Colombia
4 Participants4 Participants5 Participants13 Participants
Region of Enrollment
France
4 Participants3 Participants7 Participants14 Participants
Region of Enrollment
Germany
5 Participants5 Participants6 Participants16 Participants
Region of Enrollment
India
69 Participants65 Participants65 Participants199 Participants
Region of Enrollment
Israel
7 Participants1 Participants3 Participants11 Participants
Region of Enrollment
Italy
2 Participants7 Participants2 Participants11 Participants
Region of Enrollment
Japan
4 Participants8 Participants6 Participants18 Participants
Region of Enrollment
Peru
6 Participants10 Participants10 Participants26 Participants
Region of Enrollment
Poland
1 Participants3 Participants2 Participants6 Participants
Region of Enrollment
Spain
0 Participants1 Participants2 Participants3 Participants
Region of Enrollment
Turkey
4 Participants2 Participants0 Participants6 Participants
Region of Enrollment
United Kingdom
4 Participants8 Participants4 Participants16 Participants
Region of Enrollment
United States
70 Participants71 Participants45 Participants186 Participants
Sex: Female, Male
Female
113 Participants117 Participants113 Participants343 Participants
Sex: Female, Male
Male
95 Participants91 Participants63 Participants249 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
1 / 2070 / 2050 / 1780 / 321
other
Total, other adverse events
165 / 207166 / 205148 / 178210 / 321
serious
Total, serious adverse events
41 / 20745 / 20538 / 17859 / 321

Outcome results

Primary

The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5

At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation

Time frame: Day1 (Baseline) and Month 5 (Day150)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DE-109 44 µgThe Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 528 Participants
DE-109 440 µgThe Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 544 Participants
DE-109 880 µgThe Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 527 Participants
Secondary

VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)

At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)

Time frame: Day1/Baseline and Day150/Month 5

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DE-109 44 µgVH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)84 Participants
DE-109 440 µgVH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)104 Participants
DE-109 880 µgVH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)70 Participants
Secondary

VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)

At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible

Time frame: Day1/Baseline and Day150/Month 5

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DE-109 44 µgVH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)43 Participants
DE-109 440 µgVH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)56 Participants
DE-109 880 µgVH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)33 Participants
Other Pre-specified

VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)

At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible

Time frame: Day1/Baseline and Day180/Month 6

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DE-109 44 µgVH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)81 Participants
DE-109 440 µgVH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)90 Participants
DE-109 880 µgVH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)66 Participants
Other Pre-specified

VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)

At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible

Time frame: Day1/Baseline and Day180/Month 6

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DE-109 44 µgVH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)42 Participants
DE-109 440 µgVH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)52 Participants
DE-109 880 µgVH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)26 Participants
Other Pre-specified

VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)

At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation

Time frame: Day1/Baseline and Day180/Month 6

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DE-109 44 µgVH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)29 Participants
DE-109 440 µgVH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)43 Participants
DE-109 880 µgVH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)51 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026