Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

This study has been completed.
Information provided by (Responsible Party):
Melvin Rabena, California Retina Consultants Identifier:
First received: August 5, 2008
Last updated: December 10, 2013
Last verified: December 2013
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 Intervention Phase
Age Related Macular Degeneration
Choroidal Neovascularization
Macular Edema
Drug: Bevacizumab and verteporfin photodynamic therapy
Drug: Bevacizumab and visudyne photodynamic therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:

Further study details as provided by California Retina Consultants:

Primary Outcome Measures:
  • Visual Acuity: Percentage of patients losing 3 or more lines(15 letters) of visual acuity from baseline. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  • Visual acuity: Percentage of patients gaining 3 or more lines(15 letters) of VA from baseline. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ocular or systemic adverse events [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: May 2006
Study Completion Date: July 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Reduced Fluence
Drug: Bevacizumab and verteporfin photodynamic therapy
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.
Other Name: Avastin, visudyne
Experimental: B
Standard Fluence
Drug: Bevacizumab and visudyne photodynamic therapy
Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy.
Other Name: avastin, visudyne


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00729846

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
Principal Investigator: Dante J Pieramici, MD California Retina Consultants
  More Information

No publications provided

Responsible Party: Melvin Rabena, Director of Research, California Retina Consultants Identifier: NCT00729846     History of Changes
Other Study ID Numbers: BPDT2006 
Study First Received: August 5, 2008
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by California Retina Consultants:
choroidal neovascularization
macular degeneration
macular edema
intravitreal bevacizumab
verteporfin PDT

Additional relevant MeSH terms:
Choroidal Neovascularization
Macular Degeneration
Macular Edema
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Uveal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Dermatologic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on February 08, 2016