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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 (32-009)

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ClinicalTrials.gov Identifier: NCT02251938
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

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.

Condition or disease Intervention/treatment Phase
Non-Infectious Uveitis of the Posterior Segment of the Eye Drug: DE-109 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 24, 2014
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: DE-109 Sirolimus
Medium dose of DE-109
Drug: DE-109
Medium Dose of DE-109
Other Name: Sirolimus




Primary Outcome Measures :
  1. Safety Parameters [ Time Frame: 12 months ]
    Adverse event incidence rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251938


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Sponsors and Collaborators
Santen Inc.
Investigators
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Study Director: Lanita Scott, MD Santen Inc.

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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT02251938     History of Changes
Other Study ID Numbers: 32-009
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs