- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04138420
Evaluation of Retinal and Vascular Features in Macular Degeneration After Intravitreal Injections of Bevacizumab
Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Bevacizumab in Exudative Age-related Macular Degeneration
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bevacizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment for exudative age-related macular degeneration acting on vascular hyperpermeability.
The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed and quantitative analysis of retinal and vascular features.
The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of Bevacizumab in exudative AMD.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Naples, Italy, 80100
- University of Naples "Federico II"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age older than 50 years, diagnosis of exudative age-related macular degeneration, treatment-naïve with Bevacizumab for exudative age-related macular degeneration.
Exclusion Criteria:
- age younger than 50 years, diagnosis of exudative macular degeneration due to other causes, previous treatments before Bevacizumab for exudative age-related macular degeneration.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients receiving Bevacizumab
Bevacizumab, intravitreal injection, three monthly, dosage: 1.25 mg/0.05
mL.
|
Three monthly intravitreal injections of bevacizumab (1.25 mg/0.05
mL)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study of retinal structural features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab
Time Frame: three months
|
The effectiveness of Bevacizumab injections for treating exudative age-related macular degeneration using optical coherence tomography.
The parameters analyzed by optical coherence tomography: Central Macular Thickness and Subfoveal Choroidal thickness (microns).
|
three months
|
Study of retinal vascular features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab
Time Frame: three months
|
The effectiveness of Bevacizumab injections for treating exudative age-related macular degeneration using optical coherence tomography angiography.
The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillaris vessel density (%).
|
three months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gilda Cennamo, MD, Federico II University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT1124/14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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