Back to resultsA Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program (SPRING)
Primary Purpose
Non-Infectious Uveitis of the Posterior Segment of the Eye
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DE-109 440 μg
Sponsored by
About this trial
This is an interventional treatment trial for Non-Infectious Uveitis of the Posterior Segment of the Eye
Eligibility Criteria
Inclusion Criteria:
- Participated in the SAKURA study
- Received clinical benefit from treatment in the SAKURA study
- Ability to sign informed consent and attend all study visits
Exclusion Criteria:
- Uveitis of infectious etiology
- Implanted device
- Suspected or confirmed central nervous system or ocular lymphoma
- Uncontrolled glaucoma
- Significant ocular disease
- Intravitreal injections in the past 60 days
- Intraocular surgery or treatment
- Ocular or periocular infection
- History of herpetic infection
- Toxoplasmosis or toxoplasmosis scar
- Ocular malignancy
- Vitrectomy
- Allergy or hypersensitivity to study drug
- Participation in other uveitis device clinical trials within 30 days
- Any recent systemic condition/infection
- Immunosuppressive therapy or immunocomprimised
- Cytomegalovirus infection
- Malignancy in remission
- Females who are pregnant or lactating and who are not using adequate contraceptive
- Medical marijuana or illegal drug use
- Systemic saroidosis
- Therapeutic radiation to the head or neck
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DE-109 Sirolimus
Arm Description
DE-109 440 μg
Outcomes
Primary Outcome Measures
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye
Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision.
Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point.
Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.
Ophthalmoscopy findings were reported as normal or abnormal.
Changes From Baseline in Vitreous Haze (VH) Scores at Month 12
Vitreous Haze (VH) scores were measured using the modified Standardized Uveitis Nomenclature Photographic Scale (SUN) :
0 No inflammation
0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
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+
Moderate blurring of the optic nerve head
Marked blurring of the optic nerve head
Optic Nerve head not visible
Number of Subjects Who Receive Rescue Therapy.
Rescue therapy was defined as any treatment that would have a therapeutic effect on the uveitis in the posterior segment (e.g., systemic treatment with an immunosuppressant agent, or a corticosteroid injection in the study eye) other than intravitreal DE-109 determined by the Investigator.
Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.
Ophthalmoscopy findings were reported as normal or abnormal.
Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.
Ophthalmoscopy findings were reported as normal or abnormal.
Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye.
Ophthalmoscopy findings were reported as normal or abnormal.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02251938
Brief Title
A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
Acronym
SPRING
Official Title
A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 29, 2014 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
Detailed Description
This is a multicenter, open-label, extension study of intravitreal injections of the 440 μg dose of DE-109 in subjects with non-infectious uveitis of the posterior segment who received any dose of DE-109 and exited the SAKURA program under Santen Protocol 32-007, Amendment 05.
Subjects who were randomized and received at least two injections of DE-109 during the first five months of the SAKURA program and obtained clinical benefit from the study medication, as determined by the Investigator, may be considered for entry in this 12-month extension study. The minimum time lag from last injection in the SAKURA program to entry into the current protocol is 60 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Infectious Uveitis of the Posterior Segment of the Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DE-109 Sirolimus
Arm Type
Experimental
Arm Description
DE-109 440 μg
Intervention Type
Drug
Intervention Name(s)
DE-109 440 μg
Other Intervention Name(s)
Sirolimus
Intervention Description
Medium Dose
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye
Description
Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision.
Time Frame
Day 1 (Baseline) and Month 12 or early termination visit
Title
Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye
Description
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point.
Time Frame
Day 1 (Baseline) and Month 12 or early termination visit
Title
Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.
Description
Ophthalmoscopy findings were reported as normal or abnormal.
Time Frame
Day 1 (Baseline) and Month 12 or early termination visit
Title
Changes From Baseline in Vitreous Haze (VH) Scores at Month 12
Description
Vitreous Haze (VH) scores were measured using the modified Standardized Uveitis Nomenclature Photographic Scale (SUN) :
0 No inflammation
0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
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+
Moderate blurring of the optic nerve head
Marked blurring of the optic nerve head
Optic Nerve head not visible
Time Frame
Day 1 (Baseline) and Month 12 or early termination visit
Title
Number of Subjects Who Receive Rescue Therapy.
Description
Rescue therapy was defined as any treatment that would have a therapeutic effect on the uveitis in the posterior segment (e.g., systemic treatment with an immunosuppressant agent, or a corticosteroid injection in the study eye) other than intravitreal DE-109 determined by the Investigator.
Time Frame
By Month12
Title
Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.
Description
Ophthalmoscopy findings were reported as normal or abnormal.
Time Frame
Day 1 (Baseline) and Month 12 or early termination visit
Title
Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.
Description
Ophthalmoscopy findings were reported as normal or abnormal.
Time Frame
Day 1 (Baseline) and Month 12 or early termination visit
Title
Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye.
Description
Ophthalmoscopy findings were reported as normal or abnormal.
Time Frame
Day 1 (Baseline) and Month 12 or early termination visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participated in the SAKURA study
Received clinical benefit from treatment in the SAKURA study
Ability to sign informed consent and attend all study visits
Exclusion Criteria:
Uveitis of infectious etiology
Implanted device
Suspected or confirmed central nervous system or ocular lymphoma
Uncontrolled glaucoma
Significant ocular disease
Intravitreal injections in the past 60 days
Intraocular surgery or treatment
Ocular or periocular infection
History of herpetic infection
Toxoplasmosis or toxoplasmosis scar
Ocular malignancy
Vitrectomy
Allergy or hypersensitivity to study drug
Participation in other uveitis device clinical trials within 30 days
Any recent systemic condition/infection
Immunosuppressive therapy or immunocomprimised
Cytomegalovirus infection
Malignancy in remission
Females who are pregnant or lactating and who are not using adequate contraceptive
Medical marijuana or illegal drug use
Systemic saroidosis
Therapeutic radiation to the head or neck
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lanita Scott, MD
Organizational Affiliation
Santen Inc.
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Golden
State/Province
Colorado
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
City
Jackson
State/Province
Michigan
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
New Brunswick
State/Province
New Jersey
Country
United States
City
Palisades Park
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Orchard Park
State/Province
New York
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Graz
Country
Austria
City
Paris
Country
France
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
City
Aurobindo Marg
State/Province
New Dehli
Country
India
City
Daryaganj
State/Province
New Dehli
Country
India
City
Bhubaneswar
State/Province
Odisha
Country
India
City
Chennai
State/Province
Tamil Nadu
Country
India
City
Madurai
State/Province
Tamil Nadu
Country
India
City
Noida
State/Province
Uttar Pradesh
Country
India
City
Milano
Country
Italy
City
Ankara
Country
Turkey
City
Izmir
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
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