Clinical trial NCT05038371: Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration
Official title: Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Wet Macular Degeneration
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Olix Pharmaceuticals, Inc.
First posted: 2021-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Measurement of aqueous humor levels of CTGF by ELISA
timeFrame: Baseline visit
measure: Measurement of aqueous humor levels of VEGF by ELISA
timeFrame: Baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute at Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Peter A Campochiaro, M.D.
role: PRINCIPAL_INVESTIGATOR
References: