Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05038371

Enrollment

Registered

2021-09-09

Start date

2021-09-01

Completion date

2022-09-22

Last updated

2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Macular Degeneration

Brief summary

Age-related macular degeneration (AMD) remains a leading cause of blindness in United States and can be broadly divided into two forms: non-neovascular AMD (NNVAMD) and neovascular AMD (NVAMD) AMD. Among the several mechanisms underlying AMD, hypoxia and oxidative stress have been implicated and cause upregulation of several signaling proteins. About 20% of patients with NNVAMD develop choroidal neovascularization and hence convert to NVAMD. Upregulation of vascular endothelial growth factor (VEGF) plays a critical role in conversion from NNVAMD to NVAMD. Connective tissue growth factor (CTGF) is a polypeptide that has been shown to be overexpressed in various fibrotic disorders, suggesting its involvement in scarring. After the development of choroidal neovascularization, subretinal fibrosis may occur and result in permanent reduction of vision. An important question is, does CTGF contribute to subretinal fibrosis. An important first step in addressing this question is to determine if CTGF levels are increased in the eyes of patients with NVAMD and this is the objective of this study. The investigators plan to measure levels of connective tissue growth factor (CTGF) in the aqueous humor of patients with neovascular age-related macular degeneration and compare to controls. Levels of VEGF will be measured as a positive control.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \>/= 18 years * Willing to sign informed consent and authorization of use and disclosure of protected health information * For study group: patients must have a clinical diagnosis of NVAMD * For control group: patients undergoing vitrectomy for macular hole, macular pucker, or vitreomacular traction, vitreous floaters or another condition unrelated to scarring.

Exclusion criteria

* Subjects with a retinal condition other than NVAMD in which scarring may occur such as proliferative vitreoretinopathy or retinal detachment.

Design outcomes

Primary

Measure	Time frame	Description
Measurement of aqueous humor levels of CTGF by ELISA	Baseline visit	Connective tissue growth factor (CTGF) levels will be measured, using ELISA, in aqueous samples of both patients and controls.
Measurement of aqueous humor levels of VEGF by ELISA	Baseline visit	Vascular endothelial growth factor (VEGF) levels will be measured, using ELISA, in aqueous samples of both patients and controls. Levels of VEGF will serve as a positive control.

Countries

United States

Outcome results