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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04707625
Collaborator
(none)
10
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1
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aflibercept Ophthalmic
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All patients will receive the same standard of care treatment.All patients will receive the same standard of care treatment.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Oct 6, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Drug: Aflibercept Ophthalmic
Anti-vascular endothelial growth factor intraocular injection
Other Names:
  • Eylea
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    1. 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

    2. 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)

    3. Number of Intravitreal Injections [Baseline through week 52]

      Number of injections received during study participation

    4. 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

    5. 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

    6. 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

    7. 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

    8. 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

    9. Change in Analytes - Proteins [Baseline through week 52]

      Programmed death-ligand 1(PD-L1)/B7 homolog 1(B7-H1) Analyzed using an ELISA multiplex

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

    • Principal Investigator: Mark Nelson, MD, Wake Forest Baptist Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04707625
    Other Study ID Numbers:
    • IRB00064405
    First Posted:
    Jan 13, 2021
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Wake Forest University Health Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 6, 2022