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

Primary Purpose

Age-Related Macular Degeneration

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DE-120

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Macular Degeneration

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Low Dose DE-120

Medium Dose DE-120

High Dose DE-120

Arm Description

Single 20 µL intravitreal injection of Low Dose DE-120 injectable solution

Single 20 µL intravitreal injection of Medium Dose DE-120 injectable solution

Single 20 µL intravitreal injection of High Dose DE-120 injectable solution

Outcomes

Primary Outcome Measures

Number of subjects with adverse events

Adverse events will be assessed at each visit to assess safety

Change from Baseline in central subfield thickness (CST)

CST will be measured using spectral domain optical coherence tomography (SD-OCT)

Change from Baseline in macular volume

Macular volume will be measured using spectral domain optical coherence tomography (SD-OCT)

Drug concentration in plasma over time after a single injection of DE-120

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

Change from Baseline in ocular signs and symptoms

Ocular signs and ocular symptoms will be collected at each visit using slit lamp biomicroscopy, corrected visual acuity, ophthalmoscopy and intraocular pressure measurements

Full Information

NCT ID

NCT02022501

First Posted

December 20, 2013

Last Updated

April 16, 2018

Sponsor

Santen Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02022501

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

April 21, 2016 (Actual)

Study Completion Date

April 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Santen Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

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

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Dose DE-120

Arm Type

Experimental

Arm Description

Single 20 µL intravitreal injection of Low Dose DE-120 injectable solution

Arm Title

Medium Dose DE-120

Arm Type

Experimental

Arm Description

Single 20 µL intravitreal injection of Medium Dose DE-120 injectable solution

Arm Title

High Dose DE-120

Arm Type

Experimental

Arm Description

Single 20 µL intravitreal injection of High Dose DE-120 injectable solution

Intervention Type

Drug

Intervention Name(s)

DE-120

Primary Outcome Measure Information:

Title

Number of subjects with adverse events

Description

Adverse events will be assessed at each visit to assess safety

Time Frame

Each visit from Day 1 to Study Exit (Month 24)

Title

Change from Baseline in central subfield thickness (CST)

Description

CST will be measured using spectral domain optical coherence tomography (SD-OCT)

Time Frame

Each visit from Day 1 through Study Exit (Month 24)

Title

Change from Baseline in macular volume

Description

Macular volume will be measured using spectral domain optical coherence tomography (SD-OCT)

Time Frame

Each visit from Day 1 through Study Exit (Month 24)

Title

Drug concentration in plasma over time after a single injection of DE-120

Description

Time Frame

Most visits from Day 1 through Study Exit (Month 24)

Secondary Outcome Measure Information:

Title

Change from Baseline in ocular signs and symptoms

Description

Ocular signs and ocular symptoms will be collected at each visit using slit lamp biomicroscopy, corrected visual acuity, ophthalmoscopy and intraocular pressure measurements

Time Frame

Each visit from Day 1 through Study Exit (Month 24)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

City

Bakersfield

State/Province

California

Country

United States

City

Beverly Hills

State/Province

California

Country

United States

City

Dallas

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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