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

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05038371
Collaborator
Olix Pharmaceuticals, Inc. (Industry)
20
1
16
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration
    Actual Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of aqueous humor levels of CTGF by ELISA [Baseline visit]

      Connective tissue growth factor (CTGF) levels will be measured, using ELISA, in aqueous samples of both patients and controls.

    2. Measurement of aqueous humor levels of VEGF by ELISA [Baseline visit]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wilmer Eye Institute at Johns Hopkins University Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University
    • Olix Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Peter A Campochiaro, M.D., Johns Hopkins School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT05038371
    Other Study ID Numbers:
    • IRB00255963
    First Posted:
    Sep 9, 2021
    Last Update Posted:
    Sep 9, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 9, 2021