Study Assessing Double-masked Uveitis Treatment (SAKURA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Santen Inc.
Sponsor:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT01358266
First received: May 19, 2011
Last updated: July 17, 2012
Last verified: June 2011
  Purpose

The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.


Condition Intervention Phase
Uvea; Posterior, Disorder
Drug: DE-109
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis

Resource links provided by NLM:


Further study details as provided by Santen Inc.:

Primary Outcome Measures:
  • Proportion of subjects with vitreous haze score [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: May 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ophthalmic solution low dose Drug: DE-109
Low dose
Other Name: Sirolimus
Active Comparator: Ophthalmic solution medium dose Drug: DE-109
Medium dose
Other Name: Sirolimus
Active Comparator: Ophthalmic solution high dose Drug: DE-109
High dose
Other Name: Sirolimus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of active uveitis
  • 18 years of age or older
  • Sign informed consent
  • Meet best corrected ETDRS visual acuity

Exclusion Criteria:

  • Uveitis of infectious etiology
  • Suspected/confirmed central nervous system or ocular lymphoma
  • Primary diagnosis of anterior uveitis
  • Uncontrolled glaucoma
  • Use of topical oculary medication
  • Implanted device
  • Significant ocular disease
  • Lens/media opacities or obscured ocular media
  • Intraocular surgery or treatments
  • Capsulotomy
  • Ocular or periocular infection
  • Pupillary dilation
  • History of herpetic infection
  • Toxoplasmosis or toxoplasmosis scar
  • Ocular malignancy
  • Allergy or hypersensitivity to study drug
  • Participation in other uveitis trial within 30 days
  • Monoclonal antibody treatment or biologic therapy
  • Any systemic condition/infection
  • Immunosuppressive therapy or immunocompromised
  • Malignancy remission
  • Females who are pregnant or lactating and females not using adequate contraceptives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358266

Contacts
Contact: Mihoko Suzuki Harr clinicaltrials@santeninc.com

  Show 149 Study Locations
Sponsors and Collaborators
Santen Inc.
Investigators
Study Director: Laura Wilson, MD Santen Inc.
  More Information

No publications provided

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01358266     History of Changes
Other Study ID Numbers: 32-007
Study First Received: May 19, 2011
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014