NCT04707625

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

Terminated Phase 4 Results posted Last updated 24 February 2025

What this trial tests

Phase 4 trial testing Aflibercept Ophthalmic in Retinal Vein Occlusion in 17 participants. Terminated before completion.

Timeline

6 October 2021

Primary endpoint
18 December 2023

18 December 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	17
Start date	6 October 2021
Primary completion	18 December 2023
Estimated completion	18 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Aflibercept Ophthalmic

Conditions studied

• Retinal Vein Occlusion — all drugs for Retinal Vein Occlusion →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Retinal Vein Occlusion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Macular Edema Primary · Baseline through week 35

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

Group	Value	95% CI
Aflibercept	-504.4	± 300.82

Change in Macular Volume Primary · Baseline through week 35

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

Group	Value	95% CI
Aflibercept	-5.2	± 4.0

Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber Primary · Baseline through week 35

Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis

Group	Value	95% CI
Aflibercept	-203.5	± 203.5

Change in Best Corrected Visual Acuity (BCVA) Secondary · Baseline through week 35

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

Group	Value	95% CI
Aflibercept	-0.33	± 0.43

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Risk Factors and Treatment Strategy for Retinal Vascular Occlusive Diseases.
   Terao R, Fujino R, Ahmed T. · · 2022 · cited 29× · PMID 36362567 · DOI 10.3390/jcm11216340