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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Infectious Uveitis of the Posterior Segment of the Eye
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 participated in the SAKURA development program.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye
timeFrame: Day 1 (Baseline) and Month 12 or early termination visit
measure: Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye
timeFrame: Day 1 (Baseline) and Month 12 or early termination visit
measure: Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.
timeFrame: Day 1 (Baseline) and Month 12 or early termination visit
measure: Changes From Baseline in Vitreous Haze (VH) Scores at Month 12
timeFrame: Day 1 (Baseline) and Month 12 or early termination visit
measure: Number of Subjects Who Receive Rescue Therapy.
timeFrame: By Month12
measure: Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.
timeFrame: Day 1 (Baseline) and Month 12 or early termination visit
measure: Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.
timeFrame: Day 1 (Baseline) and Month 12 or early termination visit
measure: Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye.
timeFrame: Day 1 (Baseline) and Month 12 or early termination visit
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Sacramento
country: United States
state: California
city: Golden
country: United States
state: Colorado
city: Tampa
country: United States
state: Florida
city: Oak Park
country: United States
state: Illinois
city: Jackson
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: New Brunswick
country: United States
state: New Jersey
city: Palisades Park
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Austin
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Graz
country: Austria
city: Paris
country: France
city: Hyderabad
country: India
state: Andhra Pradesh
city: Aurobindo Marg
country: India
state: New Dehli
city: Daryaganj
country: India
state: New Dehli
city: Bhubaneswar
country: India
state: Odisha
city: Chennai
country: India
state: Tamil Nadu
city: Madurai
country: India
state: Tamil Nadu
city: Noida
country: India
state: Uttar Pradesh
city: Milano
country: Italy
city: Ankara
country: Turkey
city: Izmir
country: Turkey
Study officials:
affiliation: Santen Inc.
name: Lanita Scott, MD
role: STUDY_DIRECTOR
References: