Clinical trial NCT02401945: A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Keywords: Macular Degeneration
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in BCVA at Month 8
timeFrame: Month 8
Secondary outcomes:
measure: Change from baseline in total lesion area at Month 8
timeFrame: Month 8
measure: Change from baseline in greatest linear dimension of the area of leakage at Month 8
timeFrame: Month 8
measure: Change in Central Subfield Thickness at Month 8
timeFrame: Month 8
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Golden
country: United States
state: Colorado
city: Altamonte Springs
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Portsmouth
country: United States
state: New Hampshire
city: Charlotte
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
References: