Study Assessing Double-masked Uveitis Treatment

Phase 3

Completed

• Conditions: Uveitis; Posterior, Disorder
• Interventions: Drug: DE-109 880 ug; Drug: DE-109 44 ug; Drug: DE-109 440 ug

• Registration Number: NCT01358266
• Lead Sponsor: Santen Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Results First Submitted: 2018-05-08
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-21
• Results First Posted: 2019-07-16
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ophthalmic solution high dose	DE-109 880 ug	-
Ophthalmic solution low dose	DE-109 44 ug	-
Ophthalmic solution medium dose	DE-109 440 ug	-

Primary Outcome Measures

Name	Time	Method
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5	Day1 (Baseline) and Month 5 (Day150)	At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification; Vitreous Haze Scale Description VH score 0 = No inflammation

Secondary Outcome Measures

Name	Time	Method
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)	Day1/Baseline and Day150/Month 5	At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex); 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+; 2. Moderate blurring of the optic nerve head; 3. Marked blurring of the optic nerve head; 4. Optic Nerve head not visible
VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)	Day1/Baseline and Day150/Month 5	At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)