Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT)

March 21, 2016 updated by: Dante Pieramici, California Retina Consultants

Combination Bevacizumab and Verteporfin (Standard and Reduced Fluence)in the Treatment of Neovascular Age-Related Macular Degeneration

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Avastin, visudyne
Device: verteporfin photodynamic therapy reduced fluence
Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2].
Other Names:
  • 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 Names:
  • Avastin, visudyne
Device: verteporfin photodynamic therapy standardfluence
Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2].

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Retina Consultants

Collaborators

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPDT2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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