Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)
Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration
1 other identifier
interventional
22
1 country
2
Brief Summary
To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2006
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
April 20, 2016
CompletedApril 20, 2016
March 1, 2016
2.3 years
August 5, 2008
February 1, 2016
March 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.
1 Year
Study Arms (2)
A
EXPERIMENTALPatients will receive combination verteporfin with photodynamic therapy at reduced fluence \[300mw/cm2\] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
B
EXPERIMENTALPatients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
Interventions
Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
Patients will receive combination verteporfin photodynamic therapy with stand fluence \[600mW/cm2\].
Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\].
Eligibility Criteria
You may qualify if:
- Patients are men or women of age 50 or older.
- Patients have not received previous treatment for subfoveal choroidal neovascularization (CNV).
- Patients must have evidence of active or recurrent subfoveal CNV as confirmed by fluorescein angiography.
- The total lesion must be less than or equal to 9 disc areas in size, with a greatest linear distance of 5400 microns.
- Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye. Only one eye will assessed in the study.
- The CNV lesion must be primarily CNV (i.e. CNV equal to or greater than 50% of the lesion.
- The CNV is associated with only macular degeneration.
- Patient defers other approved treatments of subfoveal CNV associated with AMD.
You may not qualify if:
- Prior treatment for subfoveal choroidal neovascularization (CNV).
- Prior treatment for juxtafoveal or extrafoveal CNV involving previous antiangiogenic agent, photodynamic therapy, or intravitreal triamcinolone acetate.
- History of vitrectomy or submacular surgery in the study eye.
- Subretinal fibrosis accounting for more than 50% of the lesion.
- Non-CNV lesion components account for more than 50% of the total lesion components.
- CNV due to causes other than AMD.
- Retinal pigmented epithelial tear involving the center of the macula.
- Geographic atrophy involving the central macula.
- Any concurrent intraocular condition in the study eye that in the opinion of the investigator could require surgical or medical intervention during the course of the study (i.e. cataract).
- Active intraocular inflammation.
- Vitreous hemorrhage in the eye.
- History of spherical equivalent in the study eye greater than negative 8 diopters.
- Intraocular surgery within 2 months of study enrollment.
- Uncontrolled glaucoma in the study eye. Defined as intraocular pressure greater than 30mmHg despite treatment with anti-glaucoma medication.
- History of other disease, such as recent myocardial infarction, recent cerebral vascular accident, or uncontrolled hypertension that in the opinion of the investigator might render the subject at high risk for complication.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- California Retina Consultantslead
- Novartiscollaborator
Study Sites (2)
California Retina Consultants
Bakersfield, California, 93309, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Research
- Organization
- California Retina Consultants
Study Officials
- PRINCIPAL INVESTIGATOR
Dante J Pieramici, MD
California Retina Consultants
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 8, 2008
Study Start
May 1, 2006
Primary Completion
August 1, 2008
Study Completion
July 1, 2009
Last Updated
April 20, 2016
Results First Posted
April 20, 2016
Record last verified: 2016-03