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NCT04138420 Clinical Trial

Evaluation of Retinal and Vascular Features in Macular Degeneration After Intravitreal Injections of Bevacizumab

Exudative Age-related Macular Degeneration Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04138420
Other study ID # PT1124/14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 25, 2017
Est. completion date October 30, 2017

Study information
Verified date October 2019
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the retinal and vascular features in patients with macular degeneration under the effects of Bevacizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date October 30, 2017
Est. primary completion date October 25, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bevacizumab Injection
Three monthly intravitreal injections of bevacizumab (1.25 mg/0.05 mL)

Locations
Country Name City State
Italy University of Naples "Federico II" Naples

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study of retinal structural features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab 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
Primary Study of retinal vascular features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab 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
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