Overview

This trial is active, not recruiting.

Condition uveitis; posterior, disorder
Treatments de-109
Phase phase 3
Sponsor Santen Inc.
Start date May 2011
End date September 2016
Trial size 592 participants
Trial identifier NCT01358266, 32-007

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
de-109 Sirolimus
Low dose
(Active Comparator)
de-109 Sirolimus
Medium dose
(Active Comparator)
de-109 Sirolimus
High dose

Primary Outcomes

Measure
Proportion of subjects with vitreous haze score
time frame: 5 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Santen Inc..