Status:
COMPLETED
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
Lead Sponsor:
Santen Inc.
Conditions:
Non-Infectious Uveitis of the Posterior Segment of the Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 partici...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02251938
Start Date
September 29 2014
End Date
November 27 2017
Last Update
February 12 2020
Active Locations (25)
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1
Phoenix, Arizona, United States
2
Sacramento, California, United States
3
Golden, Colorado, United States
4
Tampa, Florida, United States