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

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT04138420

Collaborator

(none)

Enrollment

Location

9.1

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exudative Age-related Macular Degeneration	Drug: Bevacizumab Injection

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 Design

Study Type:

Observational

Actual Enrollment :

38 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 25, 2017

Actual Primary Completion Date :

Oct 25, 2017

Actual Study Completion Date :

Oct 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Patients receiving Bevacizumab Bevacizumab, intravitreal injection, three monthly, dosage: 1.25 mg/0.05 mL.	Drug: Bevacizumab Injection Three monthly intravitreal injections of bevacizumab (1.25 mg/0.05 mL) Other Names: Avastin

Arm

Intervention/Treatment

Patients receiving Bevacizumab

Bevacizumab, intravitreal injection, three monthly, dosage: 1.25 mg/0.05 mL.

Drug: Bevacizumab Injection

Three monthly intravitreal injections of bevacizumab (1.25 mg/0.05 mL)

Other Names:

Avastin

Outcome Measures

Primary Outcome Measures

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 (%).

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.