A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
NCT ID: NCT02555306
Last Updated: 2020-01-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2015-09-16
2017-08-31
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 Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration
NCT02401945
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
NCT03211234
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT04615325
Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration
NCT04537884
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.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low Dose DE-122
Single intravitreal injection of DE-122 Low Dose Injectable Solution
0.5 mg of DE-122
DE-122 Injectable Solution
Medium-Low Dose DE-122
Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution
1.0 mg of DE-122
DE-122 Injectable Solution
Medium-High Dose DE-122
Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution
2.0 mg of DE-122
DE-122 Injectable Solution
High Dose DE-122
Single intravitreal injection of DE-122 High Dose Injectable Solution
4.0 mg of DE-122
DE-122 Injectable Solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
0.5 mg of DE-122
DE-122 Injectable Solution
1.0 mg of DE-122
DE-122 Injectable Solution
2.0 mg of DE-122
DE-122 Injectable Solution
4.0 mg of DE-122
DE-122 Injectable Solution
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
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.
Mountain View, California, United States
Walnut Creek, California, United States
Jackson, Michigan, United States
Austin, Texas, United States
McAllen, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
36-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.