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

NCT05038371 | Terminated

• 1 other identifier: IRB00255963
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Patients with neovascular age-related macular degeneration

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of twenty eligible patients, 10 with NVAMD and 10 controls will be enrolled. Patients and controls will be identified and recruited through the clinic population of co-investigators at the Wilmer Eye Institute.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Olix Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples will only be used for measurement of biomarkers mentioned.

MeSH Terms

Conditions

Wet Macular Degeneration

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Peter A Campochiaro, M.D.

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 9, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 22, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)