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

NCT ID: NCT05038371

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-09-22

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.

Conditions

Wet Macular Degeneration

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with neovascular age-related macular degeneration

This will include 10 subjects with a diagnosis of age-related macular degeneration.

No interventions assigned to this group

Controls

This group will comprise 10 participants who plan to undergo vitrectomy for macular hole, macular pucker, or vitreomacular traction, vitreous floaters or another condition unrelated to scarring.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter A Campochiaro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00255963

Identifier Type: -

Identifier Source: org_study_id