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

Santen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Age-Related Macular Degeneration

Treatments: Drug: DE-120

Study type: Interventional

Funder types: Industry

Identifiers

NCT02022501

35-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Low Dose DE-120

Experimental group

Description:

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

Treatment:

Drug: DE-120

Medium Dose DE-120

Experimental group

Description:

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

Treatment:

Drug: DE-120

High Dose DE-120

Experimental group

Description:

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

Treatment:

Drug: DE-120