Study Assessing Double-masked Uveitis Treatment (SAKURA)

This study is currently recruiting participants.
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
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 April 20, 2014