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
Completed · Phase 3
Conditions studied: Non-Infectious Uveitis of the Posterior Segment of the Eye
In brief
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.
Key facts
- Study ID
- NCT02251938
- Run by
- Santen Inc.
- People needed
- 60
- Starts
- 2014-09-29
- Expected to finish
- 2017-11-27
- Last updated by the study team
- 2020-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participated in the SAKURA study
- Received clinical benefit from treatment in the SAKURA study
- Ability to sign informed consent and attend all study visits
You may not qualify if…
- 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
Where it is running
- Study site — Phoenix, Arizona, United States
- Study site — Sacramento, California, United States
- Study site — Golden, Colorado, United States
- Study site — Tampa, Florida, United States
- Study site — Oak Park, Illinois, United States
- Study site — Jackson, Michigan, United States
- Study site — St Louis, Missouri, United States
- Study site — New Brunswick, New Jersey, United States
- Study site — Palisades Park, New Jersey, United States
- Study site — New York, New York, United States
- Study site — Orchard Park, New York, United States
- Study site — Austin, Texas, United States
- Study site — Salt Lake City, Utah, United States
- Study site — Graz, Austria
- Study site — Paris, France
- Study site — Hyderabad, Andhra Pradesh, India
- Study site — Aurobindo Marg, New Dehli, India
- Study site — Daryāganj, New Dehli, India
- Study site — Bhubaneswar, Odisha, India
- Study site — Chennai, Tamil Nadu, India
- Study site — Madurai, Tamil Nadu, India
- Study site — Noida, Uttar Pradesh, India
- Study site — Milan, Italy
- Study site — Ankara, Turkey (Türkiye)
- Study site — Izmir, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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