A Multicenter, Randomized, Open Label, Phase IIa Study Assessing the Efficacy, Safety and Duration of Effect of Intravitreal Injections of DE-120 as Monotherapy and With a Single Eylea® Injection in Subjects With Treatment-Naive Exudative Age-Related Macular Degeneration

Santen Inc.0 sites16 target enrollmentApril 2015

ConditionsAge-Related Macular Degeneration

InterventionsDE-120 Aflibercept

DrugsDE-120 Aflibercept

Overview

Phase: Phase 2
Intervention: DE-120
Conditions: Age-Related Macular Degeneration
Sponsor: Santen Inc.
Enrollment: 16
Primary Endpoint: Mean change from baseline in BCVA at Month 8
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT) administration of DE-120 in subjects with treatment-naive active subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

October 31, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide signed written informed consent
•Diagnosis of active CNV secondary to wet AMD, with some subfoveal component in the study eye
•No evidence of subfoveal fibrosis or subfoveal RPE atrophy in the study eye
•At least one lesion in the study eye that meets minimal pathology criteria
•Best corrected visual acuity of 70 to 25 ETDRS letters in the study eye
•Best corrected visual acuity of 20/320 or better in the fellow eye
•Reasonably clear media and some fixation in the study eye

Exclusion Criteria

•Aphakic or has an anterior chamber intraocular lens in the study eye
•Received prior treatment with anti-VEGF, intravitreal corticosteroids or photodynamic therapy in the study eye
•Uncontrolled glaucoma despite anti-glaucoma therapy in the study eye
•Evidence of any ocular disease other than AMD in the study eye that may confound the outcome of the study
•History of vitrectomy in the study eye
•Need for ocular surgery in the study eye during the course of the trial
•Presence or history of certain ocular or periocular pathology or conditions that could limit ability to perform required study assessments in either eye and/or confound study results
•Allergy or hypersensitivity to study drug product, fluorescein dye or other study-related procedures and medications
•Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study
•Participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study

Arms & Interventions

DE-120 Monotherapy

DE-120 intravitreal injection given as monotherapy on a PRN basis

Intervention: DE-120

Eylea® and DE-120 Concomitant Therapy

DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.

Intervention: DE-120

Eylea® and DE-120 Concomitant Therapy

DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.

Intervention: Aflibercept

Outcomes

Primary Outcomes

Mean change from baseline in BCVA at Month 8

Time Frame: Month 8

Secondary Outcomes

Change from baseline in greatest linear dimension of the area of leakage at Month 8(Month 8)
Change from baseline in total lesion area at Month 8(Month 8)
Change in Central Subfield Thickness at Month 8(Month 8)