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

Phase 3CompletedNCT02251938

Santen Inc.60 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Infectious Uveitis of the Posterior Segment of the Eye

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participated in the SAKURA study 2. Received clinical benefit from treatment in the SAKURA study 3. Ability to sign informed consent and attend all study visits Exclusion Criteria: 1. Uveitis of infectious etiology 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

Locations (25)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Sacramento, California, United States

Unnamed facility

Golden, Colorado, United States

Unnamed facility

Tampa, Florida, United States

Unnamed facility

Oak Park, Illinois, United States

Unnamed facility

Jackson, Michigan, United States

Unnamed facility

St Louis, Missouri, United States

Unnamed facility

New Brunswick, New Jersey, United States

Unnamed facility

Palisades Park, New Jersey, United States

Unnamed facility

New York, New York, United States

...and 15 more locations

Outcomes

Primary Outcomes

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.