This is an open label, non-controlled, dose-escalating study assessing the safety, tolerability, and bioactivity of a single intravitreal (i.vt.) injection of RBM-007 in approximately nine subjects with exudative age-related macular degeneration.
Nine subjects in three dose cohorts (3 subjects each cohort) will receive a single i.vt. injection of RBM-007 in the study eye. Subjects will be followed through Day 56.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
(No additional description)
Retinal Consultants Medical Group
Sacramento, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Stanford University
Stanford, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Ocular Safety as Assessed Using Biomicroscopy to Investigate Ocular Tolerability
Biomicroscopy is used by an ophthalmologist to assess the health of the front of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Time frame: Day 56
Ocular Safety as Assessed Using Ophthalmoscopy to Investigate Ocular Tolerability
Ophthalmoscopy is used by an ophthalmologist to assess the health of the back of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.
Time frame: Day 56
Ocular Tolerability as Assessed by Number and Nature of Adverse Events
Adverse events (ocular or non-ocular)
Time frame: Day 56
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