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

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DE-120
Aflibercept
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DE-120 Monotherapy

Eylea® and DE-120 Concomitant Therapy

Arm Description

DE-120 intravitreal injection given as monotherapy on a PRN basis

DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.

Outcomes

Primary Outcome Measures

Mean change from baseline in BCVA at Month 8

Secondary Outcome Measures

Change from baseline in total lesion area at Month 8
Change from baseline in greatest linear dimension of the area of leakage at Month 8
Change in Central Subfield Thickness at Month 8

Full Information

First Posted
March 20, 2015
Last Updated
April 16, 2018
Sponsor
Santen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02401945
Brief Title
A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration
Acronym
VAPOR1
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 Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 22, 2016 (Actual)
Study Completion Date
October 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DE-120 Monotherapy
Arm Type
Experimental
Arm Description
DE-120 intravitreal injection given as monotherapy on a PRN basis
Arm Title
Eylea® and DE-120 Concomitant Therapy
Arm Type
Experimental
Arm Description
DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.
Intervention Type
Drug
Intervention Name(s)
DE-120
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea®
Primary Outcome Measure Information:
Title
Mean change from baseline in BCVA at Month 8
Time Frame
Month 8
Secondary Outcome Measure Information:
Title
Change from baseline in total lesion area at Month 8
Time Frame
Month 8
Title
Change from baseline in greatest linear dimension of the area of leakage at Month 8
Time Frame
Month 8
Title
Change in Central Subfield Thickness at Month 8
Time Frame
Month 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Bakersfield
State/Province
California
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Golden
State/Province
Colorado
Country
United States
City
Altamonte Springs
State/Province
Florida
Country
United States
City
Fort Myers
State/Province
Florida
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Portsmouth
State/Province
New Hampshire
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
McAllen
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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