Back to resultsIntravitreal Bevacizumab and Low Fluence Photodynamic Therapy
Primary Purpose
Myopia
Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Combination therapy "IVB + rf-PDT"
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Myopic CNV, CNV leakage
Exclusion Criteria:
- CNV not associated with high myopia
- No activity of CNV
Sites / Locations
- Ophthalmology Department SUN
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab and verteporfin
Arm Description
Outcomes
Primary Outcome Measures
BCVA improved
Secondary Outcome Measures
no CNV leakage
Full Information
NCT ID
NCT00802126
First Posted
December 2, 2008
Last Updated
February 5, 2016
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT00802126
Brief Title
Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy
Official Title
Efficacy of Combining Intravitreal Bevacizumab With Photodynamic Therapy Using Reduced Light Fluence Rate in Choroidal Neovascularization Secondary to Pathologic Myopia.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab and verteporfin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Combination therapy "IVB + rf-PDT"
Other Intervention Name(s)
Combined therapy: IVB + rf-PDT
Intervention Description
low-fluence photodynamic therapy combined with intravitreal bevacizumab
Primary Outcome Measure Information:
Title
BCVA improved
Time Frame
6 months
Secondary Outcome Measure Information:
Title
no CNV leakage
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Myopic CNV, CNV leakage
Exclusion Criteria:
CNV not associated with high myopia
No activity of CNV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Rinaldi, MD, PhD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Study Director
Facility Information:
Facility Name
Ophthalmology Department SUN
City
Napoli
ZIP/Postal Code
80100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy
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