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Trial record 2 of 2 for:    de-120

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT02401945
First received: March 20, 2015
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Age-Related Macular Degeneration Drug: DE-120 Drug: Aflibercept Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Santen Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: April 2015
Study Completion Date: October 31, 2016
Primary Completion Date: June 22, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02401945

Locations
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

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT02401945     History of Changes
Other Study ID Numbers: 35-002
Study First Received: March 20, 2015
Last Updated: May 12, 2017

Keywords provided by Santen Inc.:
Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 23, 2017