A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration

Overview

The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).

Full Title of Study: “A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2017

Interventions

  • Drug: DE-122
    • DE-122 Injectable Solution

Arms, Groups and Cohorts

  • Experimental: Low Dose DE-122
    • Single intravitreal injection of Low Dose DE-122 Injectable Solution
  • Experimental: Medium-Low Dose DE-122
    • Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution
  • Experimental: Medium-High Dose DE-122
    • Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution
  • Experimental: High Dose DE-122
    • Single intravitreal injection of High Dose DE-122 Injectable Solution

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects with adverse events
    • Time Frame: From Visit 1 (Day 1) to Study Exit (Day 90)

Secondary Measures

  • Change from Baseline in central subfield thickness (CST)
    • Time Frame: From Visit 1 (Day 1) to Study Exit (Day 90)
  • Change from Baseline in macular volume
    • Time Frame: From Visit 1 (Day 1) to Study Exit (Day 90)
  • Change from Baseline in Best Corrected Visual Acuity
    • Time Frame: From Visit 1 (Day 1) to Study Exit (Day 90)

Participating in This Clinical Trial

Inclusion Criteria

  • Provide signed written informed consent
  • Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration
  • Prior treatment in the study eye with any intravitreal anti-VEGF medication
  • At least one lesion in the study eye that meets minimal pathology criteria
  • Best corrected visual acuity of 65 to 20 ETDRS letters in the study eye
  • Best corrected visual acuity of 20/200 or better in the fellow eye
  • Reasonably clear media and some fixation in the study eye

Exclusion Criteria

Ocular

  • Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1
  • Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
  • Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
  • Need for ocular surgery in the study eye during the course of the study
  • Presence or history of certain ocular or periocular pathology or conditions that could limit the 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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Santen Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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