A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration

Phase 2

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: DE-120; Drug: Aflibercept

• Registration Number: NCT02401945
• Lead Sponsor: Santen Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Study Start: 2015-04
• Primary Completion: 2016-06-22
• Study Completion: 2016-10-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Ocular

• 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

Non-Ocular

• 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
• Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study
• Unable to comply with study procedures or follow-up visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DE-120 Monotherapy	DE-120	DE-120 intravitreal injection given as monotherapy on a PRN basis
Eylea® and DE-120 Concomitant Therapy	DE-120	DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.
Eylea® and DE-120 Concomitant Therapy	Aflibercept	DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in BCVA at Month 8	Month 8

Secondary Outcome Measures

Name	Time	Method
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