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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05038371
Other study ID # IRB00255963
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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