LUMINA Phase III Study Assessing the Efficacy and Safety... | NCT03711929 | Trialant
NCT03711929
Sponsor
Santen Inc.
Status
Terminated
Last Update Posted
Dec 4, 2023Actual
Enrollment
145Actual
Phase
Phase 3
Conditions
Non Infectious Uveitis
Interventions
DE-109 Intravitreal Injections
Sham Procedure
DE-109 Intravitreal Injections
DE-109 Intravitreal Injections (Open Label)
Countries
United States
Argentina
India
Italy
Protocol Section
Identification Module
NCT ID
NCT03711929
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
010906IN
Secondary IDs
Not provided
Brief Title
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
Official Title
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.
Acronym
Not provided
Organization
Santen Inc.INDUSTRY
Status Module
Record Verification Date
Nov 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business decision
Expanded Access Info
No
Start Date
Nov 19, 2018Actual
Primary Completion Date
Jun 14, 2022Actual
Completion Date
Jun 14, 2022Actual
First Submitted Date
Oct 17, 2018
First Submission Date that Met QC Criteria
Oct 17, 2018
First Posted Date
Oct 19, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Aug 24, 2023
Results First Submitted that Met QC Criteria
Nov 8, 2023
Results First Posted Date
Dec 4, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 8, 2023
Last Update Posted Date
Dec 4, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Santen Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Non Infectious Uveitis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
145Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Test Arm: DE-109 Injectable Solution
Experimental
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
Drug: DE-109 Intravitreal Injections
Control Arm: Sham Procedure
Sham Comparator
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Other: Sham Procedure
Dummy Arm: DE-109 Injectable Solution
Other
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
Drug: DE-109 Intravitreal Injections
Open-label:DE-109 Injectable Solution
Experimental
Subjects completing the Month 6 pre-dose evaluations (the final evaluations in the double-masked period) began the open-label period of the study, in which all subjects received intravitreal injection of DE-109 440 μg in the study eye(s) every 2 months for an additional 6 months of dosing.
Drug: DE-109 Intravitreal Injections (Open Label)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DE-109 Intravitreal Injections
Drug
440 ug of DE-109 Injectable Solution
Test Arm: DE-109 Injectable Solution
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Vitreous Haze (VH) of Zero Response at Month 5
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows:
Score = 0: No inflammation
Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex)
Score = 1+: Mild blurring of the retinal vessels and optic nerve
Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+
Score = 2+: Moderate blurring of the optic nerve head
Score = 3+: Marked blurring of the optic nerve head
Score = 4+: Optic nerve head not visible
VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale.
The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 5
Month 5
Secondary Outcomes
Measure
Description
Time Frame
Mean Composite Score at Month 3 and Month 5
Composite score scale is defined as follows. Each study eye was assigned one of the following scores:
Score = 3 if a study eye achieved Vitreous Haze (VH) score of 0 at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.
Score = 2 if a study eye had at least improved (decreased) by 2 units (i.e., 2+ to 0, 3+ to 1+, or 4+ to 2+) in VH (compared to baseline) at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.
Score = 1 if a study eye achieved VH score of 0.5+ at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.
Score = -1 if a study eye got rescued due to worsening of uveitis or discontinued from the study due to lack of efficacy or due to adverse event prior to the specified visit.
Score = 0 if otherwise
Other Outcomes
Not provided
Eligibility Module
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
Hashida N, Nishida K. Recent advances and future prospects: Current status and challenges of the intraocular injection of drugs for vitreoretinal diseases. Adv Drug Deliv Rev. 2023 Jul;198:114870. doi: 10.1016/j.addr.2023.114870. Epub 2023 May 10.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Study Eyes
Arm/Group Information
ID
Title
Description
FG000
Test Arm: DE-109 Injectable Solution
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution.
The sham procedure mimics an intravitreal injection without penetrating the eye.
Control Arm: Sham Procedure
DE-109 Intravitreal Injections
Drug
Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
Dummy Arm: DE-109 Injectable Solution
DE-109 Intravitreal Injections (Open Label)
Drug
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)
Open-label:DE-109 Injectable Solution
Month 3, Month 5
Vitreous Haze (VH) of Zero Response at Month 3
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows:
Score = 0: No inflammation
Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex)
Score = 1+: Mild blurring of the retinal vessels and optic nerve
Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+
Score = 2+: Moderate blurring of the optic nerve head
Score = 3+: Marked blurring of the optic nerve head
Score = 4+: Optic nerve head not visible
VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale.
The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 3.
Polo Universita degli Studi di Milano Ospedale Luigi Sacco Clinca Oculistica (Eye Clinic)
Milan
Lombardy
20157
Italy
Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica
Padova
Veneto
35128
Italy
A.O.U. Policlinico SantOrsola-Malpigi
Bologna
40138
Italy
San Raffaele Scientific Institute
Milan
20122
Italy
Azienda USL IRCCS Reggio Emilia
Reggio Emilia
42123
Italy
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
FG002
Dummy Arm: DE-109 Injectable Solution
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm.
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug).
FG00057 subjects65 unitsUnits assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
FG00159 subjects68 unitsUnits assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
FG00229 subjects32 unitsUnits assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
COMPLETED
FG00051 subjects59 unitsUnits assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
FG00148 subjects55 unitsUnits assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
FG00224 subjects27 unitsUnits assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
NOT COMPLETED
FG0006 subjects6 units
FG00111 subjects13 units
FG0025 subjects5 units
Open Label Treatment Period (OLTP)
Type
Comment
Milestone Data
STARTED
FG00042 subjects49 unitsSome participants exited the study or got rescued during Double Masked Treatment Period, hence, less participants entered the Open Label Treatment Period in the Test arm. Units assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
FG00140 subjects47 unitsSome participants exited the study or got rescued during Double Masked Treatment Period, hence, less participants entered the Open Label Treatment Period in the Control arm. Units assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
FG00221 subjects24 unitsSome participants exited the study or got rescued during Double Masked Treatment Period, hence, less participants entered the Open Label Treatment Period in the Dummy arm. Units assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
COMPLETED
FG00034 subjects40 unitsUnits assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
FG00135 subjects41 unitsUnits assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
FG00215 subjects16 unitsUnits assigned to Arm/Group are whole participants. If participants enrolled both eyes to the study, both eyes received the same assigned intervention.
NOT COMPLETED
FG0008 subjects9 units
FG0015 subjects6 units
FG0026 subjects8 units
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Test Arm: DE-109 Injectable Solution
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
BG001
Control Arm: Sham Procedure
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
BG002
Dummy Arm: DE-109 Injectable Solution
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm (which has the same route of administration and frequency as the test arm).
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00057
BG00159
BG00229
BG003145
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00046.8± 17.26
BG00146.2± 14.40
BG00247.0± 14.27
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<65
Title
Measurements
BG00047
BG00152
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00036
BG00135
BG002
Race (NIH/OMB)
The sum of the participants in the "total" Arm/Group is 145 and is consistent with the overall number of Baseline Participants of 145.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
Region of Enrollment
Number
participants
Title
Denominators
Categories
Argentina
Title
Measurements
BG00012
BG0019
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Vitreous Haze (VH) of Zero Response at Month 5
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows:
Score = 0: No inflammation
Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex)
Score = 1+: Mild blurring of the retinal vessels and optic nerve
Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+
Score = 2+: Moderate blurring of the optic nerve head
Score = 3+: Marked blurring of the optic nerve head
Score = 4+: Optic nerve head not visible
VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale.
The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 5
Full Analysis Set
Posted
Number
percentage response of study eyes
Month 5
Study Eyes
Study Eyes
ID
Title
Description
OG000
Test Arm: DE-109 Injectable Solution
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
OG001
Control Arm: Sham Procedure
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
OG002
Dummy Arm: DE-109 Injectable Solution
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm.
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
Units
Counts
Participants
OG00057
OG00159
OG00229
Study Eyes
OG000
Title
Denominators
Categories
Title
Measurements
OG00015.7
OG00112.2
OG00228.7
Secondary
Mean Composite Score at Month 3 and Month 5
Composite score scale is defined as follows. Each study eye was assigned one of the following scores:
Score = 3 if a study eye achieved Vitreous Haze (VH) score of 0 at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.
Score = 2 if a study eye had at least improved (decreased) by 2 units (i.e., 2+ to 0, 3+ to 1+, or 4+ to 2+) in VH (compared to baseline) at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.
Score = 1 if a study eye achieved VH score of 0.5+ at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.
Score = -1 if a study eye got rescued due to worsening of uveitis or discontinued from the study due to lack of efficacy or due to adverse event prior to the specified visit.
Score = 0 if otherwise
Full Analysis Set. The number of overall participants analyzed is consistent with data here and other parts of the record. Data represented in all records are for whole participants. Subjects with two study eyes had the composite score as the average score of both eyes.
Posted
Mean
Standard Deviation
score on a scale
Month 3, Month 5
ID
Title
Description
OG000
Test Arm: DE-109 Injectable Solution
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
OG001
Control Arm: Sham Procedure
Secondary
Vitreous Haze (VH) of Zero Response at Month 3
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows:
Score = 0: No inflammation
Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex)
Score = 1+: Mild blurring of the retinal vessels and optic nerve
Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+
Score = 2+: Moderate blurring of the optic nerve head
Score = 3+: Marked blurring of the optic nerve head
Score = 4+: Optic nerve head not visible
VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale.
The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 3.
Full Analysis Set
Posted
Number
percentage response of study eyes
Month 3
Study Eyes
Study Eyes
ID
Title
Description
OG000
Test Arm: DE-109 Injectable Solution
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
OG001
Control Arm: Sham Procedure
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
Time Frame
Adverse events were collected from the time of informed consent and were followed to resolution or until the subject's participation in the study ended for both periods: 6-month Double-Masked Treatment Period at Month 6; and 6-month Open-Label Treatment Period at Month 12.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DE-109 440 μg (Double Masked Treatment Period)
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
DE-109 Intravitreal Injections: 440 ug of DE-109 Injectable Solution
0
57
7
57
47
57
EG001
Sham Procedure (Double Masked Treatment Period)
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm).
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Sham Procedure: The sham procedure mimics an intravitreal injection without penetrating the eye.
OG002
Dummy Arm: DE-109 Injectable Solution
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm.
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
Units
Counts
Participants
OG00057
OG00159
OG00229
Title
Denominators
Categories
Month 3
Title
Measurements
OG0000.4± 1.10
OG0010.3± 0.80
OG0020.4± 0.98
Month 5
Title
Measurements
OG0000.3± 1.11
OG0010.3± 1.04
OG0020.6± 1.31
OG002
Dummy Arm: DE-109 Injectable Solution
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). This study arm has the same route of administration and frequency as the test arm.
DE-109 Intravitreal Injections: Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)