Back to resultsA Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration (PAVE)
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
0.5 mg of DE-122
1.0 mg of DE-122
2.0 mg of DE-122
4.0 mg of DE-122
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Macular Degeneration
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Low Dose DE-122
Medium-Low Dose DE-122
Medium-High Dose DE-122
High Dose DE-122
Arm Description
Single intravitreal injection of DE-122 Low Dose Injectable Solution
Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution
Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution
Single intravitreal injection of DE-122 High Dose Injectable Solution
Outcomes
Primary Outcome Measures
Change From Baseline in Best Corrected Visual Acuity (BCVA) at 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
Change From Baseline in Central Subfield Thickness (CST) at Day 90.
Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02555306
Brief Title
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
Acronym
PAVE
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 16, 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose DE-122
Arm Type
Experimental
Arm Description
Single intravitreal injection of DE-122 Low Dose Injectable Solution
Arm Title
Medium-Low Dose DE-122
Arm Type
Experimental
Arm Description
Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution
Arm Title
Medium-High Dose DE-122
Arm Type
Experimental
Arm Description
Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution
Arm Title
High Dose DE-122
Arm Type
Experimental
Arm Description
Single intravitreal injection of DE-122 High Dose Injectable Solution
Intervention Type
Drug
Intervention Name(s)
0.5 mg of DE-122
Intervention Description
DE-122 Injectable Solution
Intervention Type
Drug
Intervention Name(s)
1.0 mg of DE-122
Intervention Description
DE-122 Injectable Solution
Intervention Type
Drug
Intervention Name(s)
2.0 mg of DE-122
Intervention Description
DE-122 Injectable Solution
Intervention Type
Drug
Intervention Name(s)
4.0 mg of DE-122
Intervention Description
DE-122 Injectable Solution
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.
Description
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.
Time Frame
Baseline (Day1) and Day 90.
Secondary Outcome Measure Information:
Title
Change From Baseline in Central Subfield Thickness (CST) at Day 90.
Description
Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.
Time Frame
Baseline (Day1) and Day 90.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
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