Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects

Study Overview
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Brief Summary
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To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.

Official Title
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A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Wet Age-related Macular Degeneration - AVANTE Study

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: 2.0 mg DE-122 Injectable Solution + Lucentis
* Drug: 4.0 mg DE-122 Injectable Solution + Lucentis
* Drug: Lucentis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed written informed consent Diagnosis of active choroidal neovascularization secondary to wet AMD BCVA of 65 to 25 ETDRS letters (20/50 to 20/320) in the study eye BCVA of 25 ETDRS letters (20/320) or better in the fellow 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 and throughout the study 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 examinations [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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2.0 mg DE-122<br>2.0 mg DE-122 and Lucentis ® 0.5 mg | Drug: 2.0 mg DE-122 Injectable Solution + Lucentis<br>* Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.<br>|
| Experimental: 4.0 mg DE-122<br>4.0 mg DE-122 and Lucentis ® 0.5 mg | Drug: 4.0 mg DE-122 Injectable Solution + Lucentis<br>* Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.<br>|
| Sham Comparator: Sham<br>Sham and Lucentis ® 0.5 mg | Drug: Lucentis<br>* Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24 | BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint. An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision. | Week 24 |