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

NCT04138420 | Completed

• 1 other identifier: PT1124/14
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Exudative Age-related Macular Degeneration

Keywords

optical coherence tomography angiography; optical coherence tomography angiography angiography; bevacizumab; vascular endothelial growth factor antagonists; intravitreal injection

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Patients receiving Bevacizumab

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

Drug: Bevacizumab Injection

Interventions

Bevacizumab Injection DRUG

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

Also known as: Avastin

Patients receiving Bevacizumab

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participans were older than 50 years with diagnosis of exudative age-relative macular degeneration. They did not present other ophthalmological disease and did not receive previous treatment before Bevacizumab.

You may qualify if:

• age older than 50 years, diagnosis of exudative age-related macular degeneration, treatment-naïve with Bevacizumab for exudative age-related macular degeneration.

You may not qualify if:

• age younger than 50 years, diagnosis of exudative macular degeneration due to other causes, previous treatments before Bevacizumab for exudative age-related macular degeneration.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gilda Cennamo, MD

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gilda Cennamo

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: October 24, 2019
• Study Start: January 25, 2017
• Primary Completion: October 25, 2017
• Study Completion: October 30, 2017
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

IT (1)