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

Wet Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05038371
• Other study ID #: IRB00255963
• Status: Terminated
• Start date: September 1, 2021
• Est. completion date: September 22, 2022

Study information

• Verified date: September 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 22, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Locations

Country	Name	City	State
United States	Wilmer Eye Institute at Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Olix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of aqueous humor levels of CTGF by ELISA	Connective tissue growth factor (CTGF) levels will be measured, using ELISA, in aqueous samples of both patients and controls.	Baseline visit
Primary	Measurement of aqueous humor levels of VEGF by ELISA	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.	Baseline visit