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Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
California Retina Consultants
ClinicalTrials.gov Identifier:
NCT00729846
First received: August 5, 2008
Last updated: December 1, 2010
Last verified: December 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729846

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

No publications provided

Responsible Party: Dante Pieramici M.D., California Retina Consultants
ClinicalTrials.gov Identifier: NCT00729846     History of Changes
Other Study ID Numbers: BPDT2006
Study First Received: August 5, 2008
Last Updated: December 1, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Edema
Macular Degeneration
Macular Edema
Neovascularization, Pathologic
Wet Macular Degeneration
Choroidal Neovascularization
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
 Verteporfin
Bevacizumab
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013