Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy - Full Text View

Sponsored by:	Second University of Naples
Information provided by:	Second University of Naples
ClinicalTrials.gov Identifier:	NCT00802126

Purpose

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.

Condition	Intervention	Phase
Myopia	Drug: Combination therapy "IVB + rf-PDT"	Phase I

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Combining Intravitreal Bevacizumab With Photodynamic Therapy Using Reduced Light Fluence Rate in Choroidal Neovascularization Secondary to Pathologic Myopia.

Further study details as provided by Second University of Naples:

Primary Outcome Measures:

BCVA improved [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

no CNV leakage [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Bevacizumab and verteporfin: Experimental	Drug: Combination therapy "IVB + rf-PDT" low-fluence photodynamic therapy combined with intravitreal bevacizumab

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.

Eligibility

Ages Eligible for Study:	35 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Myopic CNV, CNV leakage

Exclusion Criteria:

CNV not associated with high myopia
No activity of CNV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802126

Locations

Italy
Ophthalmology Department SUN
Napoli, Italy, 80100

Sponsors and Collaborators

Second University of Naples

Investigators

Study Director:

Michele Rinaldi, MD, PhD

Second University of Naples

More Information

Responsible Party:	seconda Università degli Studi di Napoli ( Ophthalmology Department )
Study ID Numbers:	81613
Study First Received:	December 2, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00802126
Health Authority:	Italy: Ethics Committee

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Neoplasm Metastasis
Bevacizumab

Neovascularization, Pathologic
Myopia
Refractive Errors
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Antineoplastic Agents
Therapeutic Uses
Growth Substances

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009