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

NCT02022501 | Completed Phase 1

• 1 other identifier: 35-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Age-Related Macular Degeneration

Keywords

Macular Degeneration

Outcome Measures

Primary Outcomes (4)

• Number of subjects with adverse events

  Adverse events will be assessed at each visit to assess safety

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

• Change from Baseline in central subfield thickness (CST)

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

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

• Change from Baseline in macular volume

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

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

• 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)

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

Secondary Outcomes (1)

• Change from Baseline in ocular signs and symptoms

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

Study Arms (3)

Low Dose DE-120

EXPERIMENTAL

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

Drug: DE-120

Medium Dose DE-120

EXPERIMENTAL

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

Drug: DE-120

High Dose DE-120

EXPERIMENTAL

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

Drug: DE-120

Interventions

DE-120 DRUG

High Dose DE-120; Low Dose DE-120; Medium Dose DE-120

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (3)

Unknown Facility

Bakersfield, California, United States

Location

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: January 1, 2014
• Primary Completion: April 21, 2016
• Study Completion: April 21, 2016
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

US (3)