- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02401945
A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration (VAPOR1)
April 16, 2018 updated by: Santen Inc.
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States
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California
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Bakersfield, California, United States
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Walnut Creek, California, United States
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Colorado
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Golden, Colorado, United States
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Florida
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Altamonte Springs, Florida, United States
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Fort Myers, Florida, United States
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Indiana
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Indianapolis, Indiana, United States
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New Hampshire
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Portsmouth, New Hampshire, United States
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North Carolina
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Charlotte, North Carolina, United States
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Texas
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Dallas, Texas, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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San Antonio, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: DE-120 Monotherapy
DE-120 intravitreal injection given as monotherapy on a PRN basis
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EXPERIMENTAL: Eylea® and DE-120 Concomitant Therapy
DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Mean change from baseline in BCVA at Month 8
Time Frame: Month 8
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Month 8
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change from baseline in total lesion area at Month 8
Time Frame: Month 8
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Month 8
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Change from baseline in greatest linear dimension of the area of leakage at Month 8
Time Frame: Month 8
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Month 8
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Change in Central Subfield Thickness at Month 8
Time Frame: Month 8
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Month 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (ACTUAL)
June 22, 2016
Study Completion (ACTUAL)
October 31, 2016
Study Registration Dates
First Submitted
March 20, 2015
First Submitted That Met QC Criteria
March 24, 2015
First Posted (ESTIMATE)
March 30, 2015
Study Record Updates
Last Update Posted (ACTUAL)
April 18, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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