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Completed

NCT Number: NCT02401945

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

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).

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DE-120

Drug

aflibercept

Drug

Other names: Eylea®

Primary outcomes

  1. Mean change from baseline in BCVA at Month 8

    Time frame: Month 8

Secondary outcomes

  1. Change from baseline in total lesion area at Month 8

    Time frame: Month 8

  2. Change from baseline in greatest linear dimension of the area of leakage at Month 8

    Time frame: Month 8

  3. Change in Central Subfield Thickness at Month 8

    Time frame: Month 8

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study 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

Acronym: VAPOR1

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2015
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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