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 SAK

• Status: Completed
• Trial end date: 2017-11-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Treatments: Everolimus; Sirolimus

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