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

Retinal Vein Occlusion Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04707625
• Other study ID #: IRB00064405
• Status: Terminated
• Phase: Phase 4
• Start date: October 6, 2021
• Est. completion date: December 18, 2023

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 18, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

Drug:
• Aflibercept Ophthalmic
Anti-vascular endothelial growth factor intraocular injection

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline through week 52
Primary	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	Baseline through week 52
Primary	Change in Vascular Endothelial Growth Factor (VEGF) level in Anterior Chamber	Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis	Baseline through week 52
Secondary	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	Baseline through week 52
Secondary	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)	Baseline through week 52
Secondary	Number of Intravitreal Injections	Number of injections received during study participation	Baseline through week 52
Secondary	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	Baseline through week 52
Secondary	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	Baseline through week 52
Secondary	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	Baseline through week 52
Secondary	Change in Analytes - Interferons	Interferon (IFN)-alpha 2/IFNA2, Interferon (IFN)-beta, and Interferon (IFN)-gamma - Analyzed using an ELISA multiplex	Baseline through week 52
Secondary	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	Baseline through week 52
Secondary	Change in Analytes - Proteins	Programmed death-ligand 1(PD-L1)/B7 homolog 1(B7-H1) Analyzed using an ELISA multiplex	Baseline through week 52

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