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

NCT04707625 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00064405
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vein Occlusion

Keywords

Vision Loss; Eye Injections

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (9)

• Change in Best Corrected Visual Acuity (BCVA)

  Baseline through week 35

• Change in Intraocular Pressure (IOP)

  Baseline through week 52

• Number of Intravitreal Injections

  Baseline through week 52

• Change in Analytes - Chemokine (C-C Motif) Ligand (CCL)s

  Baseline through week 52

• Change in Analytes - Chemokine (C-X-C Motif) Ligand (CXCL)s

  Baseline through week 52

Study Arms (1)

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.

Drug: Aflibercept Ophthalmic

Interventions

Aflibercept Ophthalmic DRUG

Anti-vascular endothelial growth factor intraocular injection

Also known as: Eylea

Aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related 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.

  PMID: 26522708 BACKGROUND

• 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.

  PMID: 25068637 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.

  PMID: 24679444 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.

  PMID: 23722722 BACKGROUND

Related Links

• Eyla prescribing information

MeSH Terms

Conditions

Retinal Vein Occlusion; Vision Disorders

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

IRB terminated study early due to inappropriately enrolled participants and safety concerns.

Results Point of Contact

• Title: Mark Nelson, MD
• Organization: Wake Forest University Health Sciences

mhnelson@wakehealth.edu

336.713.1680

Study Officials

• Mark Nelson, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will receive the same standard of care treatment.

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: October 6, 2021
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)