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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 (PAVE)

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: NCT02555306
Recruitment Status : Completed
First Posted : September 21, 2015
Results First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: 0.5 mg of DE-122 Drug: 1.0 mg of DE-122 Drug: 2.0 mg of DE-122 Drug: 4.0 mg of DE-122 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 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, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration
Actual Study Start Date : September 16, 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose DE-122
Single intravitreal injection of DE-122 Low Dose Injectable Solution
Drug: 0.5 mg of DE-122
DE-122 Injectable Solution

Experimental: Medium-Low Dose DE-122
Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution
Drug: 1.0 mg of DE-122
DE-122 Injectable Solution

Experimental: Medium-High Dose DE-122
Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution
Drug: 2.0 mg of DE-122
DE-122 Injectable Solution

Experimental: High Dose DE-122
Single intravitreal injection of DE-122 High Dose Injectable Solution
Drug: 4.0 mg of DE-122
DE-122 Injectable Solution




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

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): NCT02555306


Locations
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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.
  Study Documents (Full-Text)

Documents provided by Santen Inc.:
Study Protocol  [PDF] June 30, 2016
Statistical Analysis Plan  [PDF] August 9, 2017

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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT02555306    
Other Study ID Numbers: 36-001
First Posted: September 21, 2015    Key Record Dates
Results First Posted: January 14, 2020
Last Update Posted: January 14, 2020
Last Verified: January 2020
Keywords provided by Santen Inc.:
Macular Degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases