A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration
NCT ID: NCT02401945
Last Updated: 2018-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2015-04-30
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase I/II Safety Study of DE-120 Injectable Solution for Age-related Macular Degeneration
NCT02022501
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
NCT02555306
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
NCT02540954
An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting
NCT06398080
Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
NCT04423718
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DE-120 Monotherapy
DE-120 intravitreal injection given as monotherapy on a PRN basis
DE-120
Eylea® and DE-120 Concomitant Therapy
DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.
DE-120
Aflibercept
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DE-120
Aflibercept
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Santen Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Bakersfield, California, United States
Walnut Creek, California, United States
Golden, Colorado, United States
Altamonte Springs, Florida, United States
Fort Myers, Florida, United States
Indianapolis, Indiana, United States
Portsmouth, New Hampshire, United States
Charlotte, North Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
35-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.