Phase 3 N=592 Randomized Quadruple-blind Treatment

Study Assessing Double-masked Uveitis Treatment

Uveitis; Posterior, Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01358266 ↗

Enrolled (actual)

592

Serious AEs

20.1%

Results posted

Jul 2019

Primary outcome: Primary: The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5 — 28; 44; 27 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DE-109 44 ug (Drug); DE-109 440 ug (Drug); DE-109 880 ug (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Santen Inc.
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5	28; 44; 27	—
SECONDARY VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)	43; 56; 33	—
SECONDARY VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)	84; 104; 70	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01358266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.