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Completed

NCT Number: NCT02022501

A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Bakersfield, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DE-120

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 27, 2013
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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