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Clinical Trials/NCT00802126
NCT00802126
Completed
Phase 1

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

University of Campania "Luigi Vanvitelli"1 site in 1 country16 target enrollmentNovember 2007

Overview

Phase
Phase 1
Intervention
Combination therapy "IVB + rf-PDT"
Conditions
Myopia
Sponsor
University of Campania "Luigi Vanvitelli"
Enrollment
16
Locations
1
Primary Endpoint
BCVA improved
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
May 2009
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chiosi Flavia

Chiosi Flavia

University of Campania "Luigi Vanvitelli"

Eligibility Criteria

Inclusion Criteria

  • Myopic CNV, CNV leakage

Exclusion Criteria

  • CNV not associated with high myopia
  • No activity of CNV

Arms & Interventions

Bevacizumab and verteporfin

Intervention: Combination therapy "IVB + rf-PDT"

Outcomes

Primary Outcomes

BCVA improved

Time Frame: 6 months

Secondary Outcomes

  • no CNV leakage(6 months)

Study Sites (1)

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