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

NCT ID: NCT04138420

Last Updated: 2019-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-25

Study Completion Date

2017-10-30

Brief Summary

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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

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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.

Conditions

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Exudative Age-related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving Bevacizumab

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

Bevacizumab Injection

Intervention Type DRUG

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

Interventions

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Bevacizumab Injection

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

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gilda Cennamo

Gilda Cennamo

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gilda Cennamo, MD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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University of Naples "Federico II"

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PT1124/14

Identifier Type: -

Identifier Source: org_study_id

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