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Trial record 1 of 2 for:    de-120
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A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02022501
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Brief Summary:
The purpose of this study is to assess the safety, tolerability, bioactivity and pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in subjects with late stage exudative age-related macular degeneration.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: DE-120 Phase 1 Phase 2

Detailed Description:

This is an open-label, dose-escalating, sequential-cohort study of DE-120 injectable solution administered in 9, and up to 12, subjects with late stage exudative age-related macular degeneration.

Three cohorts of 3 subjects will receive a single intravitreal injection in the study eye. Subjects in Cohort 1 will receive a single intravitreal injection of Low Dose DE-120 injectable solution in the study eye and will be evaluated through Visit 5 (Month 1). If the Low Dose is considered to be safe, the next higher dose will be administered to Cohort 2.

The same enrollment and safety review procedures will be followed for Cohort 2 (Medium Dose DE-120) and Cohort 3 (High Dose DE-120).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Pharmacokinetics and Bioactivity of a Single Intravitreal Injection of DE-120 Injectable Solution for the Treatment of Late Stage Exudative Age-related Macular Degeneration
Study Start Date : January 2014
Actual Primary Completion Date : April 21, 2016
Actual Study Completion Date : April 21, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose DE-120
Single 20 µL intravitreal injection of Low Dose DE-120 injectable solution
Drug: DE-120
Experimental: Medium Dose DE-120
Single 20 µL intravitreal injection of Medium Dose DE-120 injectable solution
Drug: DE-120
Experimental: High Dose DE-120
Single 20 µL intravitreal injection of High Dose DE-120 injectable solution
Drug: DE-120



Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: Each visit from Day 1 to Study Exit (Month 24) ]
    Adverse events will be assessed at each visit to assess safety

  2. Change from Baseline in central subfield thickness (CST) [ Time Frame: Each visit from Day 1 through Study Exit (Month 24) ]
    CST will be measured using spectral domain optical coherence tomography (SD-OCT)

  3. Change from Baseline in macular volume [ Time Frame: Each visit from Day 1 through Study Exit (Month 24) ]
    Macular volume will be measured using spectral domain optical coherence tomography (SD-OCT)

  4. Drug concentration in plasma over time after a single injection of DE-120 [ Time Frame: Most visits from Day 1 through Study Exit (Month 24) ]
    Pharmacokinetic assessments will include area under the plasma concentration time curve (AUC), peak plasma concentration (Cmax), time to peak plasma concentration (tmax) and elimination half life (t1/2)


Secondary Outcome Measures :
  1. Change from Baseline in ocular signs and symptoms [ Time Frame: Each visit from Day 1 through Study Exit (Month 24) ]
    Ocular signs and ocular symptoms will be collected at each visit using slit lamp biomicroscopy, corrected visual acuity, ophthalmoscopy and intraocular pressure measurements



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Understand and provide signed written informed consent
  • Diagnosis of chronic subretinal or intraretinal fluid secondary to exudative age-related macular degeneration in the study eye
  • At least one lesion in the study eye that meets minimal pathology criteria
  • Visual acuity of ≤ 55 ETDRS letter (20/80 Snellen equivalent) or worse in the study eye, excluding No Light Perception
  • Reasonably clear media and some fixation in the study eye

Main Exclusion Criteria:

Ocular

  • Visual acuity of No Light Perception
  • Aphakic or has an anterior chamber intraocular lens in the study eye.
  • 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 glaucoma, chronic hypotony or vitrectomy in the study eye
  • Evidence of any other ocular disease other than late stage exudative age related macular degeneration in the study eye that may confound the outcome of the study .
  • Proscribed ocular surgery in the study eye either prior to or 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

  • Systemic treatment with anti-VEGF agents (e.g., bevacizumab) is prohibited at any time during the study
  • Allergy or hypersensitivity to study drug product, fluorescein dye, or other study related procedures/medications.
  • Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for a clinical trial
  • Participation in other investigational drug or device clinical trials within 30 days prior to Screening 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022501


Locations
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United States, California
Bakersfield, California, United States
Beverly Hills, California, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Santen Inc.
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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT02022501    
Other Study ID Numbers: 35-001
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Keywords provided by Santen Inc.:
Macular Degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases