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A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration (VAPOR1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02401945
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: DE-120 Drug: Aflibercept Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : June 22, 2016
Actual Study Completion Date : October 31, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: DE-120 Monotherapy
DE-120 intravitreal injection given as monotherapy on a PRN basis
 Drug: DE-120
Experimental: Eylea® and DE-120 Concomitant Therapy
DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.
 Drug: DE-120
Drug: Aflibercept
Other Name: Eylea®


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline in BCVA at Month 8 [ Time Frame: Month 8 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401945


Locations
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United States, Arizona
Phoenix, Arizona, United States
United States, California
Bakersfield, California, United States
Walnut Creek, California, United States
United States, Colorado
Golden, Colorado, United States
United States, Florida
Altamonte Springs, Florida, United States
Fort Myers, Florida, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, New Hampshire
Portsmouth, New Hampshire, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Santen Inc.
More Information
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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT02401945    
Other Study ID Numbers: 35-002
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Keywords provided by Santen Inc.:
Macular Degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents