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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022501
• Other study ID #: 35-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 20, 2013
• Last updated: April 16, 2018
• Start date: January 2014
• Est. completion date: April 21, 2016

Study information

• Verified date: April 2018
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 21, 2016
• Est. primary completion date: April 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• DE-120

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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	Each visit from Day 1 through Study Exit (Month 24)