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

Completed

• Conditions: Exudative Age-related Macular Degeneration
• Interventions: Drug: Bevacizumab Injection

• Registration Number: NCT04138420
• Lead Sponsor: Federico II University

Brief 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.

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 Timeline

• Study Start: 2017-01-25
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-19
• Study First Submitted QC: 2019-10-22
• Last Update Submitted: 2019-10-22
• Study First Posted: 2019-10-24
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving Bevacizumab	Bevacizumab Injection	Bevacizumab, intravitreal injection, three monthly, dosage: 1.25 mg/0.05 mL.

Primary Outcome Measures

Name	Time	Method
Study of retinal structural features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab	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).
Study of retinal vascular features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab	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 (%).

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy