A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: 0.5 mg of DE-122
* Drug: 1.0 mg of DE-122
* Drug: 2.0 mg of DE-122
* Drug: 4.0 mg of DE-122


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose DE-122<br>Single intravitreal injection of DE-122 Low Dose Injectable Solution | Drug: 0.5 mg of DE-122<br>* DE-122 Injectable Solution<br>|
| Experimental: Medium-Low Dose DE-122<br>Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution | Drug: 1.0 mg of DE-122<br>* DE-122 Injectable Solution<br>|
| Experimental: Medium-High Dose DE-122<br>Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution | Drug: 2.0 mg of DE-122<br>* DE-122 Injectable Solution<br>|
| Experimental: High Dose DE-122<br>Single intravitreal injection of DE-122 High Dose Injectable Solution | Drug: 4.0 mg of DE-122<br>* DE-122 Injectable Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day1) and Day 90. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day1) and Day 90. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Degeneration