A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/2/2016
Start Date:April 2015
End Date:September 2016
Contact:Mike Rinehart
Email:clinicaltrials@santeninc.com

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A Multicenter, Randomized, Open Label, Phase IIa Study Assessing the Efficacy, Safety and Duration of Effect of Intravitreal Injections of DE-120 as Monotherapy and With a Single Eylea® Injection in Subjects With Treatment-Naive Exudative Age-Related Macular Degeneration

The purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT)
administration of DE-120 in subjects with treatment-naive active subfoveal choroidal
neovascularization (CNV) secondary to age-related macular degeneration (AMD).


Inclusion Criteria:

- Provide signed written informed consent

- Diagnosis of active CNV secondary to wet AMD, with some subfoveal component in the
study eye

- No evidence of subfoveal fibrosis or subfoveal RPE atrophy in the study eye

- At least one lesion in the study eye that meets minimal pathology criteria

- Best corrected visual acuity of 70 to 25 ETDRS letters in the study eye

- Best corrected visual acuity of 20/320 or better in the fellow eye

- Reasonably clear media and some fixation in the study eye

Exclusion Criteria:

Ocular

- Aphakic or has an anterior chamber intraocular lens in the study eye

- Received prior treatment with anti-VEGF, intravitreal corticosteroids or photodynamic
therapy in the study eye

- Uncontrolled glaucoma despite anti-glaucoma therapy in the study eye

- Evidence of any ocular disease other than AMD in the study eye that may confound the
outcome of the study

- History of vitrectomy in the study eye

- Need for ocular surgery in the study eye 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

- 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
We found this trial at
14
sites
Charlotte, North Carolina 28207
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Charlotte, NC
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Altamonte Springs, Florida 32701
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Altamonte Springs, FL
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Bakersfield, CA
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Dallas, TX
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Fort Myers, FL
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Golden, CO
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Houston, TX
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Indianapolis, IN
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McAllen, TX
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Phoenix, AZ
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Portsmouth, New Hampshire 03801
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Portsmouth, NH
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Salt Lake City, UT
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San Antonio, TX
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Walnut Creek, CA
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