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

• ClinicalTrials.gov Identifier: NCT02401945
• Recruitment Status: Completed
• First Posted: March 30, 2015
• Last Update Posted: April 18, 2018
• Sponsor: Santen Inc.
• Information provided by (Responsible Party): Santen Inc.

Tracking Information

• First Submitted Date: March 20, 2015
• First Posted Date: March 30, 2015
• Last Update Posted Date: April 18, 2018
• Study Start Date: April 2015
• Actual Primary Completion Date: June 22, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 24, 2015): Mean change from baseline in BCVA at Month 8 [ Time Frame: Month 8 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Age-Related Macular Degeneration

Intervention

• Drug: DE-120
• Drug: Aflibercept
  Other Name: Eylea®

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 22, 2016): 16
• Original Estimated Enrollment (submitted: March 24, 2015): 30
• Actual Study Completion Date: October 31, 2016
• Actual Primary Completion Date: June 22, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02401945
• Other Study ID Numbers: 35-002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Santen Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Santen Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Santen Inc.
• Verification Date: April 2018