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Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

Primary Purpose

Age Related Macular Degeneration, Choroidal Neovascularization, Macular Edema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
verteporfin photodynamic therapy reduced fluence
verteporfin photodynamic therapy standardfluence
Sponsored by
California Retina Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring choroidal neovascularization, macular degeneration, macular edema, intravitreal bevacizumab, vegf, verteporfin PDT

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Retina Consultants
  • California Retina Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2008
Last Updated
March 21, 2016
Sponsor
California Retina Consultants
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00729846
Brief Title
Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)
Official Title
Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Retina Consultants
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration, Choroidal Neovascularization, Macular Edema
Keywords
choroidal neovascularization, macular degeneration, macular edema, intravitreal bevacizumab, vegf, verteporfin PDT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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.
Arm Title
B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin, visudyne
Intervention Description
Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
Intervention Type
Device
Intervention Name(s)
verteporfin photodynamic therapy reduced fluence
Other Intervention Name(s)
PDT
Intervention Description
Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2].
Intervention Type
Device
Intervention Name(s)
verteporfin photodynamic therapy standardfluence
Intervention Description
Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2].
Primary Outcome Measure Information:
Title
Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dante J Pieramici, MD
Organizational Affiliation
California Retina Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.californiaretina.com
Description
California Retina Consultants Website

Learn more about this trial

Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

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