This trial is active, not recruiting.

Condition age-related macular degeneration
Treatments de-120, aflibercept
Phase phase 2
Target VEGF
Sponsor Santen Inc.
Start date April 2015
End date May 2016
Trial size 16 participants
Trial identifier NCT02401945, 35-002


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
DE-120 intravitreal injection given as monotherapy on a PRN basis
DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.
aflibercept Eylea®

Primary Outcomes

Mean change from baseline in BCVA at Month 8
time frame: Month 8

Secondary Outcomes

Change from baseline in total lesion area at Month 8
time frame: Month 8
Change from baseline in greatest linear dimension of the area of leakage at Month 8
time frame: Month 8
Change in Central Subfield Thickness at Month 8
time frame: Month 8

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Santen Inc..