Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF… (NCT04707625) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Macular Edema
Timeframe: Baseline through week 35
2
Change in Macular Volume
Timeframe: Baseline through week 35
3
Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber