search
Back to results

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

Primary Purpose

Retinal Vein Occlusion

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aflibercept Ophthalmic
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Retinal Vein Occlusion focused on measuring Vision Loss, Eye Injections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Wake Forest Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Aflibercept

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Macular Edema
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 Volume
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
Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis

Secondary Outcome Measures

Change in Best Corrected Visual Acuity (BCVA)
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 Intraocular Pressure (IOP)
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)
Number of Intravitreal Injections
Number of injections received during study participation
Change in Analytes - Chemokine (C-C motif) ligand (CCL)s
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 - chemokine (C-X-C motif) ligand (CXCL)s
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 - Growth factors
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
Change in Analytes - Interferons
Interferon (IFN)-alpha 2/IFNA2, Interferon (IFN)-beta, and Interferon (IFN)-gamma - Analyzed using an ELISA multiplex
Change in Analytes - Interleukins
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
Change in Analytes - Proteins
Programmed death-ligand 1(PD-L1)/B7 homolog 1(B7-H1) Analyzed using an ELISA multiplex

Full Information

First Posted
January 11, 2021
Last Updated
January 4, 2023
Sponsor
Wake Forest University Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04707625
Brief Title
Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
Vision Loss, Eye Injections

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
All patients will receive the same standard of care treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aflibercept Ophthalmic
Other Intervention Name(s)
Eylea
Intervention Description
Anti-vascular endothelial growth factor intraocular injection
Primary Outcome Measure Information:
Title
Change in Macular Edema
Description
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
Time Frame
Baseline through week 52
Title
Change in Macular Volume
Description
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
Time Frame
Baseline through week 52
Title
Change in Vascular Endothelial Growth Factor (VEGF) level in Anterior Chamber
Description
Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis
Time Frame
Baseline through week 52
Secondary Outcome Measure Information:
Title
Change in Best Corrected Visual Acuity (BCVA)
Description
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
Time Frame
Baseline through week 52
Title
Change in Intraocular Pressure (IOP)
Description
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)
Time Frame
Baseline through week 52
Title
Number of Intravitreal Injections
Description
Number of injections received during study participation
Time Frame
Baseline through week 52
Title
Change in Analytes - Chemokine (C-C motif) ligand (CCL)s
Description
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
Time Frame
Baseline through week 52
Title
Change in Analytes - chemokine (C-X-C motif) ligand (CXCL)s
Description
CXCL1/GRO alpha/KC/Cytokine-induced neutrophil chemoattractant (CINC-1) and CXCL2/GRO beta/MIP-s/CINC-3 - Analyzed using an ELISA multiplex
Time Frame
Baseline through week 52
Title
Change in Analytes - Growth factors
Description
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
Time Frame
Baseline through week 52
Title
Change in Analytes - Interferons
Description
Interferon (IFN)-alpha 2/IFNA2, Interferon (IFN)-beta, and Interferon (IFN)-gamma - Analyzed using an ELISA multiplex
Time Frame
Baseline through week 52
Title
Change in Analytes - Interleukins
Description
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
Time Frame
Baseline through week 52
Title
Change in Analytes - Proteins
Description
Programmed death-ligand 1(PD-L1)/B7 homolog 1(B7-H1) Analyzed using an ELISA multiplex
Time Frame
Baseline through week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Nelson, MD
Phone
336-713-1680
Email
mhnelson@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Blair Gordy
Phone
336-716-3937
Email
bgordy@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Nelson, MD
Organizational Affiliation
Wake Forest Baptist Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Nelson, MD
Phone
336-716-3937
Email
mhnelson@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Blair Gordy
Phone
336-716-3937
Email
bgordy@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD at this time.
Citations:
PubMed Identifier
26522708
Citation
Clark WL, Boyer DS, Heier JS, Brown DM, Haller JA, Vitti R, Kazmi H, Berliner AJ, Erickson K, Chu KW, Soo Y, Cheng Y, Campochiaro PA. Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion: 52-Week Results of the VIBRANT Study. Ophthalmology. 2016 Feb;123(2):330-336. doi: 10.1016/j.ophtha.2015.09.035. Epub 2015 Oct 30.
Results Reference
background
PubMed Identifier
25068637
Citation
Ogura Y, Roider J, Korobelnik JF, Holz FG, Simader C, Schmidt-Erfurth U, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study. Am J Ophthalmol. 2014 Nov;158(5):1032-8. doi: 10.1016/j.ajo.2014.07.027. Epub 2014 Jul 25.
Results Reference
background
PubMed Identifier
24679444
Citation
Heier JS, Clark WL, Boyer DS, Brown DM, Vitti R, Berliner AJ, Kazmi H, Ma Y, Stemper B, Zeitz O, Sandbrink R, Haller JA. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014 Jul;121(7):1414-1420.e1. doi: 10.1016/j.ophtha.2014.01.027. Epub 2014 Mar 27. Erratum In: Ophthalmology. 2014 Nov;121(11):2293.
Results Reference
background
PubMed Identifier
23722722
Citation
Falavarjani KG, Nguyen QD. Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature. Eye (Lond). 2013 Jul;27(7):787-94. doi: 10.1038/eye.2013.107. Epub 2013 May 31.
Results Reference
background
Links:
URL
https://www.regeneron.com/sites/default/files/EYLEA_FPI.pdf
Description
Eyla prescribing information

Learn more about this trial

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

We'll reach out to this number within 24 hrs