Correlation of Vascular Endothelial Growth Factor Levels in Anterior Chamber Fluid to Disease State in Patients With Retinal Vein Occlusion Receiving Standard of Care Treatment

IRB00064405

The purpose of this study is to treat patients with retinal vein occlusion with standard of care anti-vascular endothelial growth factor therapy and to correlate levels of vascular endothelial growth factor in the anterior chamber fluid of the eye. This study will evaluate if measuring the vascular endothelial growth factor will help predict the timing of when anti-vascular endothelial growth factor therapy will be needed.

2021-10-06

2023-12-18

2023-12-18

Terminated

Early phase I

17

Inclusion Criteria: * Willingness and ability to provide written informed consent. * Diagnosis of Retinal Vein Occlusion with macular edema and central foveal thickness of greater than or equal to 300 microns confirmed by intravenous fluorescein angiography and Optical Coherence Tomography * Visual Acuity between 20/25 and 5/200 Exclusion Criteria: * Bilateral Retinal Vein Occlusion * Vision worse than 5/200 in study eye * History of myocardial infarction, ischemia, or cerebrovascular accident within 6 weeks of screening * Concurrent Proliferative Diabetic Retinopathy and/or Maculopathy * Concurrent Exudative Age-related Macular Degeneration * Concurrent optic neuropathy with the presence of an afferent pupillary defect * Previous vitrectomy in the study eye * Currently pregnant or planning to become pregnant during the duration of the study. Women currently breastfeeding are also excluded. * Previous treatment for retinal vein occlusion in the study eye * Any current medical condition which, in the opinion of the investigator is considered to be uncontrolled * History of allergy or hypersensitivity to study treatment, fluorescein, or any study procedure and treatment related ingredients (e.g. topical anesthetics, betadine, etc.)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will receive the same standard of care treatment.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 17, 'type': 'ACTUAL'}}

2024-04-29