A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration
VAPOR1
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
1 other identifier
interventional
16
1 country
14
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2015
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2016
CompletedApril 18, 2018
April 1, 2018
1.2 years
March 20, 2015
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in BCVA at Month 8
Month 8
Secondary Outcomes (3)
Change from baseline in total lesion area at Month 8
Month 8
Change from baseline in greatest linear dimension of the area of leakage at Month 8
Month 8
Change in Central Subfield Thickness at Month 8
Month 8
Study Arms (2)
DE-120 Monotherapy
EXPERIMENTALDE-120 intravitreal injection given as monotherapy on a PRN basis
Eylea® and DE-120 Concomitant Therapy
EXPERIMENTALDE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Santen Inc.lead
Study Sites (14)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Golden, Colorado, United States
Unknown Facility
Altamonte Springs, Florida, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Portsmouth, New Hampshire, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
McAllen, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2015
First Posted
March 30, 2015
Study Start
April 1, 2015
Primary Completion
June 22, 2016
Study Completion
October 31, 2016
Last Updated
April 18, 2018
Record last verified: 2018-04