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
NCT ID: NCT02251938
Last Updated: 2020-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2014-09-29
2017-11-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DE-109 Sirolimus
DE-109 440 μg
DE-109 440 μg
Medium Dose
Interventions
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DE-109 440 μg
Medium Dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Received clinical benefit from treatment in the SAKURA study
3. Ability to sign informed consent and attend all study visits
Exclusion Criteria
2. Implanted device
3. Suspected or confirmed central nervous system or ocular lymphoma
4. Uncontrolled glaucoma
5. Significant ocular disease
6. Intravitreal injections in the past 60 days
7. Intraocular surgery or treatment
8. Ocular or periocular infection
9. History of herpetic infection
10. Toxoplasmosis or toxoplasmosis scar
11. Ocular malignancy
12. Vitrectomy
13. Allergy or hypersensitivity to study drug
14. Participation in other uveitis device clinical trials within 30 days
15. Any recent systemic condition/infection
16. Immunosuppressive therapy or immunocomprimised
17. Cytomegalovirus infection
18. Malignancy in remission
19. Females who are pregnant or lactating and who are not using adequate contraceptive
20. Medical marijuana or illegal drug use
21. Systemic saroidosis
22. Therapeutic radiation to the head or neck
18 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lanita Scott, MD
Role: STUDY_DIRECTOR
Santen Inc.
Locations
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Phoenix, Arizona, United States
Sacramento, California, United States
Golden, Colorado, United States
Tampa, Florida, United States
Oak Park, Illinois, United States
Jackson, Michigan, United States
St Louis, Missouri, United States
New Brunswick, New Jersey, United States
Palisades Park, New Jersey, United States
New York, New York, United States
Orchard Park, New York, United States
Austin, Texas, United States
Salt Lake City, Utah, United States
Graz, , Austria
Paris, , France
Hyderabad, Andhra Pradesh, India
Aurobindo Marg, New Dehli, India
Daryāganj, New Dehli, India
Bhubaneswar, Odisha, India
Chennai, Tamil Nadu, India
Madurai, Tamil Nadu, India
Noida, Uttar Pradesh, India
Milan, , Italy
Ankara, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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32-009
Identifier Type: -
Identifier Source: org_study_id
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