TerminatedPhase 4

Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment

Stopped: IRB stopped study due to safety concerns. No further data collection and what has been collected is not appropriate for analysis.

United States17 participantsStarted 2021-10-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

What they're measuring

Change in Macular Edema

Timeframe: Baseline through week 35

Change in Macular Volume

Timeframe: Baseline through week 35

Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber

Timeframe: Baseline through week 35

Trial details

NCT IDNCT04707625

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-18

Results submitted2024-11-13

View on ClinicalTrials.gov More Retinal Vein Occlusion trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.