Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy

Myopia Clinical Trial

Official title:

Efficacy of Combining Intravitreal Bevacizumab With Photodynamic Therapy Using Reduced Light Fluence Rate in Choroidal Neovascularization Secondary to Pathologic Myopia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802126
• Other study ID #: 81613
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2008
• Last updated: February 5, 2016
• Start date: November 2007
• Est. completion date: May 2009

Study information

• Verified date: February 2016
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to report the treatment effect and safety of combined intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to pathologic myopia.

Description:

In this retrospective interventional case series, 16 patients with myopic CNV were included. All patients were treated with 1.25 mg of intravitreal bevacizumab followed by RF-PDT (25 J/cm²), 2 days later. All patients were previously treated with IVB monotherapy and active leaking of CNV occurred 90 to 120 days after the treatment.

Best-corrected visual acuity (BCVA-ETDRS), foveal thickness (FT) on optical coherence tomography (OCT), and fluorescein and indocyanine green angiographic (FA; ICG) findings were recorded. Follow-up evaluations were carried out for 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• Myopic CNV, CNV leakage

Exclusion Criteria:

• CNV not associated with high myopia

• No activity of CNV

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia

Intervention

Drug:
• Combination therapy "IVB + rf-PDT"
low-fluence photodynamic therapy combined with intravitreal bevacizumab

Locations

Country	Name	City	State
Italy	Ophthalmology Department SUN	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA improved		6 months	Yes
Secondary	no CNV leakage		6 months	Yes