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

Phase 4

Terminated

• Conditions: Retinal Vein Occlusion
• Interventions: Drug: Aflibercept Ophthalmic

• Registration Number: NCT04707625
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Study Start: 2021-10-06
• Status Verified: 2023-12
• Primary Completion: 2023-12-18
• Study Completion: 2023-12-18
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept	Aflibercept Ophthalmic	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.

Primary Outcome Measures

Name	Time	Method
Change in Macular Volume	Baseline through week 52	Measured by central retinal thickness using optical coherence tomography - OCT is an imaging method used to generate a picture of the back of the eye, called the retina. The picture is made by precisely measuring the amount of a dim red light that reflects off the retina
Change in Macular Edema	Baseline through week 52	Measured by central retinal thickness using optical coherence tomography - OCT is an imaging method used to generate a picture of the back of the eye, called the retina. The picture is made by precisely measuring the amount of a dim red light that reflects off the retina
Change in Vascular Endothelial Growth Factor (VEGF) level in Anterior Chamber	Baseline through week 52	Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis

Secondary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP)	Baseline through week 52	Evaluated by tonometry - Tonometry is the procedure eye care professionals perform to determine the intraocular pressure (IOP), the fluid pressure inside the eye - Most tonometers are calibrated to measure pressure in millimeters of mercury (mmHg)
Change in Best Corrected Visual Acuity (BCVA)	Baseline through week 52	Using Snellen Visual Acuity charts - The results are based on what line the patient can read with ease - If a subject's visual acuity is so poor that the subject can't see any letters on the charts, finger counting and/or hand motions will be checked
Change in Analytes - Growth factors	Baseline through week 52	Epidermal growth factor (EGF) and basic fibroblast growth factor (FGF basic)/FGF2/bFGF - and Transforming growth factor alpha (TGF-alpha) - and Platelet-derived growth factor (PDGF)-AA and PDGF-AB/BBA analyzed using an ELISA multiplex Analyzed
Number of Intravitreal Injections	Baseline through week 52	Number of injections received during study participation
Change in Analytes - chemokine (C-X-C motif) ligand (CXCL)s	Baseline through week 52	CXCL1/GRO alpha/KC/Cytokine-induced neutrophil chemoattractant (CINC-1) and CXCL2/GRO beta/MIP-s/CINC-3 - Analyzed using an ELISA multiplex
Change in Analytes - Interferons	Baseline through week 52	Interferon (IFN)-alpha 2/IFNA2, Interferon (IFN)-beta, and Interferon (IFN)-gamma - Analyzed using an ELISA multiplex
Change in Analytes - Proteins	Baseline through week 52	Programmed death-ligand 1(PD-L1)/B7 homolog 1(B7-H1) Analyzed using an ELISA multiplex
Change in Analytes - Chemokine (C-C motif) ligand (CCL)s	Baseline through week 52	Chemokine (C-C motif) ligand 2 (CCL2)/(JE/MCP-1) Monocyte chemoattractant protein 1 and C-C motif chemokine 11(CCL11)/Eotaxin - Analyzed using an ELISA multiplex
Change in Analytes - Interleukins	Baseline through week 52	IL-1 alpha/IL-1F1; * IL-1 beta/IL-1F2; * IL-1ra/IL-1F3; * IL-2; * IL-3; * IL-4; * IL-5; * IL-6; * IL-7; * IL-8/CXCL8; * IL-10; * IL-12 p70; * IL-13; * IL-15; * IL-17/IL-17A; * IL-17E/IL-25; * IL-33 Analyzed using an ELISA multiplex

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States