Study Assessing Double-masKed Uveitis tReAtment - Full Text View

Study Assessing Double-masKed Uveitis tReAtment (SAKURA)

This study is currently recruiting participants.

Verified June 2011 by Santen Inc.

First Received on May 19, 2011. Last Updated on June 15, 2011 History of Changes

Sponsor:	Santen Inc.
Information provided by:	Santen Inc.
ClinicalTrials.gov Identifier:	NCT01358266

Purpose

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

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:

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

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:	March 2013
Estimated Primary Completion Date:	March 2013 (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 139 Study Locations

Sponsors and Collaborators

Santen Inc.

Investigators

Study Director:

Laura Wilson, MD

Santen Inc.

More Information

No publications provided

Responsible Party:	Naveed Shams, Santen Inc
ClinicalTrials.gov Identifier:	NCT01358266 History of Changes
Other Study ID Numbers:	32-007
Study First Received:	May 19, 2011
Last Updated:	June 15, 2011
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 May 23, 2012