Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE March 20, 2015
First Posted Date  ICMJE March 30, 2015
Last Update Posted Date April 18, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
Mean change from baseline in BCVA at Month 8 [ Time Frame: Month 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: DE-120
  • Drug: Aflibercept
    Other Name: Eylea®
Study Arms  ICMJE
  • Experimental: DE-120 Monotherapy
    DE-120 intravitreal injection given as monotherapy on a PRN basis
    Intervention: 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.
    Interventions:
    • Drug: DE-120
    • Drug: Aflibercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2016)
16
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2015)
30
Actual Study Completion Date  ICMJE October 31, 2016
Actual Primary Completion Date June 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02401945
Other Study ID Numbers  ICMJE 35-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Santen Inc.
Study Sponsor  ICMJE Santen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Santen Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP