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

Sponsor
Santen Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02401945
Collaborator
(none)
16
Enrollment
14
Locations
2
Arms
19
Duration (Months)
1.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Apr 1, 2015
Actual Primary Completion Date :
Jun 22, 2016
Actual Study Completion Date :
Oct 31, 2016

Arms and Interventions

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 Names:
  • Eylea®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean change from baseline in BCVA at Month 8 [Month 8]

    Secondary Outcome Measures

    1. Change from baseline in total lesion area at Month 8 [Month 8]

    2. Change from baseline in greatest linear dimension of the area of leakage at Month 8 [Month 8]

    3. Change in Central Subfield Thickness at Month 8 [Month 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Phoenix Arizona United States
    2 Bakersfield California United States
    3 Walnut Creek California United States
    4 Golden Colorado United States
    5 Altamonte Springs Florida United States
    6 Fort Myers Florida United States
    7 Indianapolis Indiana United States
    8 Portsmouth New Hampshire United States
    9 Charlotte North Carolina United States
    10 Dallas Texas United States
    11 Houston Texas United States
    12 McAllen Texas United States
    13 San Antonio Texas United States
    14 Salt Lake City Utah United States

    Sponsors and Collaborators

    • Santen Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Santen Inc.
    ClinicalTrials.gov Identifier:
    NCT02401945
    Other Study ID Numbers:
    • 35-002
    First Posted:
    Mar 30, 2015
    Last Update Posted:
    Apr 18, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by Santen Inc.
    Macular Degeneration
    Additional relevant MeSH terms:
    Macular Degeneration
    Aflibercept

    Study Results

    No Results Posted as of Apr 18, 2018