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Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

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ClinicalTrials.gov Identifier: NCT00729846
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : April 20, 2016
Last Update Posted : April 20, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Dante Pieramici, California Retina Consultants

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Choroidal Neovascularization Macular Edema Drug: Bevacizumab Device: verteporfin photodynamic therapy reduced fluence Device: verteporfin photodynamic therapy standardfluence Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration
Study Start Date : May 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : July 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
 Drug: Bevacizumab
Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
Other Name: Avastin, visudyne

Device: verteporfin photodynamic therapy reduced fluence
Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2].
Other Name: PDT
Experimental: B
Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
 Drug: Bevacizumab
Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
Other Name: Avastin, visudyne

Device: verteporfin photodynamic therapy standardfluence
Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2].


Outcome Measures
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Primary Outcome Measures :
  1. Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline. [ Time Frame: 1 Year ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Inability to comply with study or follow-up procedures.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729846


Locations
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United States, California
California Retina Consultants
Bakersfield, California, United States, 93309
California Retina Consultants
Santa Barbara, California, United States, 93103
Sponsors and Collaborators
California Retina Consultants
Novartis
Investigators
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Principal Investigator: Dante J Pieramici, MD California Retina Consultants
More Information
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Additional Information:

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Responsible Party: Dante Pieramici, Director of Research, California Retina Consultants
ClinicalTrials.gov Identifier: NCT00729846    
Other Study ID Numbers: BPDT2006
First Posted: August 8, 2008    Key Record Dates
Results First Posted: April 20, 2016
Last Update Posted: April 20, 2016
Last Verified: March 2016
Keywords provided by Dante Pieramici, California Retina Consultants:
choroidal neovascularization
macular degeneration
macular edema
 intravitreal bevacizumab
vegf
verteporfin PDT
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
 Bevacizumab
Verteporfin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Photosensitizing Agents
Dermatologic Agents