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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2023-12-18

Brief Summary

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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.

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Detailed Description

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Ten patients, 5 with branch retinal vein occlusion and 5 with central retinal vein occlusion, will receive stand of care anti-vascular endothelial growth factor over the course of 52 weeks while undergoing a paracentesis prior to each treatment. During the paracentesis anterior chamber fluid will be removed to evaluate vascular endothelial growth factor levels along with other cytokines present in the anterior chamber fluid. Ocular coherence tomography will also be collected at each visit to evaluate macular thickness which will be used to help determine treatment windows along with levels of vascular endothelial growth factor. Patients with high levels of vascular endothelial growth factor and the presence of macular edema on ocular coherence tomography will be treated every four weeks. Once vascular endothelial growth factor levels are reduced along with improvements of macula edema treatment windows will be extended to 8 weeks and then to 12 weeks once levels are normal and edema is no longer present.

Conditions

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Retinal Vein Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients will receive the same standard of care treatment.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Aflibercept

All subjects will receive aflibercept every 4 weeks. Once vascular endothelial growth factor levels become normal and macular edema improves treatment windows will be extended up to every 12 weeks.

Group Type OTHER

Aflibercept Ophthalmic

Intervention Type DRUG

Anti-vascular endothelial growth factor intraocular injection

Interventions

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Aflibercept Ophthalmic

Anti-vascular endothelial growth factor intraocular injection

Intervention Type DRUG

Other Intervention Names

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Eylea

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No