- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02251938
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 (SPRING)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Graz, Austria
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Paris, France
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India
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New Dehli
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Aurobindo Marg, New Dehli, India
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Daryaganj, New Dehli, India
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Odisha
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Bhubaneswar, Odisha, India
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Tamil Nadu
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Chennai, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Uttar Pradesh
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Noida, Uttar Pradesh, India
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Milano, Italy
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Ankara, Turkey
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Izmir, Turkey
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Arizona
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Phoenix, Arizona, United States
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California
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Sacramento, California, United States
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Colorado
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Golden, Colorado, United States
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Florida
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Tampa, Florida, United States
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Illinois
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Oak Park, Illinois, United States, 60304
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Michigan
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Jackson, Michigan, United States
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Missouri
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Saint Louis, Missouri, United States
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New Jersey
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New Brunswick, New Jersey, United States
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Palisades Park, New Jersey, United States
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New York
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New York, New York, United States
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Orchard Park, New York, United States
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Texas
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Austin, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: DE-109 Sirolimus
DE-109 440 μg
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Medium Dose
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye
Time Frame: Day 1 (Baseline) and Month 12 or early termination visit
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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.
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Day 1 (Baseline) and Month 12 or early termination visit
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Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye
Time Frame: Day 1 (Baseline) and Month 12 or early termination visit
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Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point.
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Day 1 (Baseline) and Month 12 or early termination visit
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Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.
Time Frame: Day 1 (Baseline) and Month 12 or early termination visit
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Ophthalmoscopy findings were reported as normal or abnormal.
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Day 1 (Baseline) and Month 12 or early termination visit
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Changes From Baseline in Vitreous Haze (VH) Scores at Month 12
Time Frame: Day 1 (Baseline) and Month 12 or early termination visit
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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)
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Day 1 (Baseline) and Month 12 or early termination visit
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Number of Subjects Who Receive Rescue Therapy.
Time Frame: By Month12
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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.
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By Month12
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Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.
Time Frame: Day 1 (Baseline) and Month 12 or early termination visit
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Ophthalmoscopy findings were reported as normal or abnormal.
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Day 1 (Baseline) and Month 12 or early termination visit
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Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.
Time Frame: Day 1 (Baseline) and Month 12 or early termination visit
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Ophthalmoscopy findings were reported as normal or abnormal.
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Day 1 (Baseline) and Month 12 or early termination visit
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Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye.
Time Frame: Day 1 (Baseline) and Month 12 or early termination visit
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Ophthalmoscopy findings were reported as normal or abnormal.
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Day 1 (Baseline) and Month 12 or early termination visit
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Lanita Scott, MD, Santen Inc.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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