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OpenTrials
Completed

NCT Number: NCT00802126

Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ophthalmology Department SUN

Naples, Napoli, 80100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myopic CNV, CNV leakage

Exclusion criteria

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

Treatment and study plan

Combination therapy "IVB + rf-PDT"

Drug

low-fluence photodynamic therapy combined with intravitreal bevacizumab

Other names: Combined therapy: IVB + rf-PDT

Primary outcomes

  1. BCVA improved

    Time frame: 6 months

Secondary outcomes

  1. no CNV leakage

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Dec 4, 2008
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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