Wet Macular DegenerationNCT05038371
Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration
An observational study of Wet Macular Degeneration, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wet Macular Degeneration
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 22 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects with a retinal condition other than NVAMD in which scarring may occur such as proliferative vitreoretinopathy or retinal detachment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, 21287
About this study
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
- Medical subject headings
- Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion22 Sep 2022
Why it stopped: The study team decided to not publish a manuscript therefore we decided to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Olix Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Peter A Campochiaro, M.D., Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038371
- Sponsor's protocol ID
- IRB00255963
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05038371
- Acronym / sponsor ID
- IRB00255963
- Conditions
- Wet Macular Degeneration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study team decided to not publish a manuscript therefore we decided to terminate the study
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Olix Pharmaceuticals, Inc.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects with a retinal condition other than NVAMD in which scarring may occur such as proliferative vitreoretinopathy or retinal detachment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of aqueous humor levels of CTGF by ELISA
Time frame: Baseline visit
Connective tissue growth factor (CTGF) levels will be measured, using ELISA, in aqueous samples of both patients and controls.
Measurement of aqueous humor levels of VEGF by ELISA
Time frame: 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.
Results and safety
The study was stopped early (reason given: The study team decided to not publish a manuscript therefore we decided to terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Campochiaro, M.D. principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Macular Degeneration, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study team decided to not publish a manuscript therefore we decided to terminate the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of aqueous humor levels of CTGF by ELISA (time frame: Baseline visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.