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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
17
Anti-vascular endothelial growth factor intraocular injection
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
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
Time frame: Baseline through week 35
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
Time frame: Baseline through week 35
Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber
Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis
Time frame: Baseline through week 35
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
Time frame: Baseline through week 35
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)
Time frame: Baseline through week 52
Number of Intravitreal Injections
Number of injections received during study participation
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Time frame: Baseline through week 52
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
Time frame: Baseline through week 52
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
Time frame: Baseline through week 52
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
Time frame: Baseline through week 52
Change in Analytes - Interferons
Interferon (IFN)-alpha 2/IFNA2, Interferon (IFN)-beta, and Interferon (IFN)-gamma - Analyzed using an ELISA multiplex
Time frame: Baseline through week 52
Change in Analytes - Proteins
Programmed death-ligand 1(PD-L1)/B7 homolog 1(B7-H1) Analyzed using an ELISA multiplex
Time frame: Baseline through week 52
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
Time frame: Baseline through week 52