A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Santen Inc.
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Provide signed written informed consent
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
You may not be if
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
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
