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OpenTrials
Completed

NCT Number: NCT02555306

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

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).

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mountain View, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

0.5 mg of DE-122

Drug

DE-122 Injectable Solution

1.0 mg of DE-122

Drug

DE-122 Injectable Solution

2.0 mg of DE-122

Drug

DE-122 Injectable Solution

4.0 mg of DE-122

Drug

DE-122 Injectable Solution

Primary outcomes

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.

    Time frame: Baseline (Day1) and Day 90.

    BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of [0, 97] in ETDRS letters.

    An increase in BCVA indicates an improvement in the best corrected vision.

Secondary outcomes

  1. Change From Baseline in Central Subfield Thickness (CST) at Day 90.

    Time frame: Baseline (Day1) and Day 90.

    Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.

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, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration

Acronym: PAVE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2015
Registry last updated
Jan 14, 2020

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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