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Trial record 1 of 1 for:    DE-122
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A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT02555306
First received: September 13, 2015
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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).

Condition Intervention Phase
Age-Related Macular Degeneration Drug: DE-122 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Santen Inc.:

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

Secondary Outcome 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) ]

Enrollment: 12
Actual Study Start Date: September 16, 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose DE-122
Single intravitreal injection of Low Dose DE-122 Injectable Solution
Drug: DE-122
DE-122 Injectable Solution
Experimental: Medium-Low Dose DE-122
Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution
Drug: DE-122
DE-122 Injectable Solution
Experimental: Medium-High Dose DE-122
Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution
Drug: DE-122
DE-122 Injectable Solution
Experimental: High Dose DE-122
Single intravitreal injection of High Dose DE-122 Injectable Solution
Drug: DE-122
DE-122 Injectable Solution

  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 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
  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: NCT02555306

Locations
United States, California
Mountain View, California, United States, 94040
Walnut Creek, California, United States, 94598
United States, Michigan
Jackson, Michigan, United States, 49202
United States, Texas
Austin, Texas, United States, 78705
McAllen, Texas, United States, 78503
Sponsors and Collaborators
Santen Inc.
  More Information

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT02555306     History of Changes
Other Study ID Numbers: 36-001
Study First Received: September 13, 2015
Last Updated: May 12, 2017

Keywords provided by Santen Inc.:
Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on June 23, 2017