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

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.

Study Overview

• Status: Terminated
• Conditions: Wet Macular Degeneration

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Wilmer Eye Institute at Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Olix Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Peter A Campochiaro, M.D., Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: IRB00255963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No