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IRB stopped study due to safety concerns. No further data collection and what has been collected is not appropriate for analysis.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept Ophthalmic | Drug | Anti-vascular endothelial growth factor intraocular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 | Baseline through week 35 |
| Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber | Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis | Baseline through week 35 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Nelson, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26522708 | Background | 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. | |
| 25068637 |
| Label | URL |
|---|---|
| Eyla prescribing information | View source |
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There is no plan to share IPD at this time.
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Participants were inappropriately enrolled; IRB required early termination due to the number of protocol violations.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Aflibercept Ophthalmic: Anti-vascular endothelial growth factor intraocular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
10 participants appropriately consented included
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Aflibercept Ophthalmic: Anti-vascular endothelial growth factor intraocular injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | IRB will not allow study team to access or analyze any data |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | IRB terminated study early and would not allow study team to access data further. | Posted | Mean | Standard Deviation | cubic microns | Baseline through week 35 |
|
up to 1 year
Although the study team reported monitoring AEs during the study prior to termination, no adverse, serious adverse or mortality events were collected prior to the IRB terminating the study for safety concerns related to the conduct of the study. Termination was not due to actual adverse, serious adverse or mortality events collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Aflibercept Ophthalmic: Anti-vascular endothelial growth factor intraocular injection |
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IRB terminated study early due to inappropriately enrolled participants and safety concerns.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Nelson, MD | Wake Forest University Health Sciences | 336.713.1680 | mhnelson@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2023 | Nov 13, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2023 | Apr 25, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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All patients will receive the same standard of care treatment.
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| 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 |
| Number of Intravitreal Injections | Number of injections received during study participation | 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 | 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 | 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 | 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 | Baseline through week 52 |
| Change in Analytes - Proteins | Programmed death-ligand 1(PD-L1)/B7 homolog 1(B7-H1) Analyzed using an ELISA multiplex | Baseline through week 52 |
| Change in Analytes - Interleukins | IL-1 alpha/IL-1F1
| Baseline through week 52 |
| 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. |
| 24679444 | Background | 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. |
| 23722722 | Background | 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. |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | IRB will not allow study team to access or analyze any data | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | IRB will not allow study team to access or analyze data any further. | Posted | Mean | Standard Deviation | cubic microns | Baseline through week 35 |
|
|
|
| Primary | Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber | Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis | IRB will not allow study team to access or analyze data any further. | Posted | Mean | Standard Deviation | pg/ml | Baseline through week 35 |
|
|
|
| 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 | IRB will not allow study team to access or analyze data any further. | Posted | Mean | Standard Deviation | LOGMAR Units | Baseline through week 35 |
|
|
|
| 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) | Not measured prior to IRB-required termination | Posted | Baseline through week 52 |
|
|
| Secondary | Number of Intravitreal Injections | Number of injections received during study participation | Not measured prior to IRB-required termination | Posted | 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 | Not measured prior to IRB-required termination | Posted | 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 | Not measured prior to IRB-required termination | Posted | 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 | Not measured prior to IRB-required termination | Posted | 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 | Not measured prior to IRB-required termination | Posted | 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 | Not measured prior to IRB-required termination | Posted | Baseline through week 52 |
|
|
| Secondary | Change in Analytes - Interleukins | IL-1 alpha/IL-1F1
| Not measured prior to IRB-required termination | Posted | Baseline through week 52 |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |