Trial Outcomes & Findings for Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment (NCT NCT04707625)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

Baseline through week 35

Results posted on

2025-02-24

Participant Flow

Participants were inappropriately enrolled; IRB required early termination due to the number of protocol violations.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	17
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study IRB Required Early Termination Due to Safety Concerns	17

Baseline Characteristics

IRB will not allow study team to access or analyze any data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aflibercept n=10 Participants 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
Age, Continuous	74.4 years STANDARD_DEVIATION 6.6 • n=10 Participants • IRB will not allow study team to access or analyze any data
Sex: Female, Male Female	6 Participants n=10 Participants • IRB will not allow study team to access or analyze any data
Sex: Female, Male Male	4 Participants n=10 Participants • IRB will not allow study team to access or analyze any data

PRIMARY outcome

Timeframe: Baseline through week 35

Population: IRB terminated study early and would not allow study team to access data further.

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

Outcome measures

Outcome measures
Measure	Aflibercept n=10 Participants 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
Change in Macular Edema	-504.4 cubic microns Standard Deviation 300.82

PRIMARY outcome

Timeframe: Baseline through week 35

Population: IRB will not allow study team to access or analyze data any further.

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

Outcome measures

Outcome measures
Measure	Aflibercept n=10 Participants 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
Change in Macular Volume	-5.2 cubic microns Standard Deviation 4.0

PRIMARY outcome

Timeframe: Baseline through week 35

Population: IRB will not allow study team to access or analyze data any further.

Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis

Outcome measures

Outcome measures
Measure	Aflibercept n=10 Participants 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
Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber	-203.5 pg/ml Standard Deviation 203.5

SECONDARY outcome

Timeframe: Baseline through week 35

Population: IRB will not allow study team to access or analyze data any further.

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