Combination Bevacizumab and Verteporfin (Two Different Sequences of Treatment)in Neovascular AMD

January 25, 2007 updated by: Retinal Consultants Medical Group

A 24 Month Randomized, Double-Masked, Single Center, Phase II Study Comparing Photodynamic Therapy With Verteporfin (Visudyne)Plus Two Different Timing Regimens of Intravitreal Bevacizumab (Avastin) Given 1 Week Prior to or 1 Week Following Photodynamic Therapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.

The purpose of this research study is to compare different timing therapies of Verteporfin with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

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
      • Sacramento, California, United States, 95819
        • Retinal Consultants Medical Group, Inc.

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients are men or women of age 55 or older
  2. Patients have subfoveal CNV due to AMD with lesion size less than or equal to 9 MPS DA
  3. patients have not received previous treatment for subfoveal CNV due to AMD.
  4. Patients have a visual acuity between 20/40 and 20/320-

Exclusion Criteria:

  1. Subjects who have received previous treatment for subfoveal CNV, in their study eye including prior PDT, transpupillary thermotherapy (TTT), submacular surgery, drug therapies such as Macugen or other anti-angiogenic compounds, or other local treatment. Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
  2. Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
  3. Patients who use medications that may induce photosensitivity.
  4. Patients who have undergone YAG capsulotomy within the last month.
  5. Subjects currently involved in any experimental procedure within the last 12 weeks.

  6. Female patients who are pregnant, fecund or breast-feeding.

    -

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: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
percentage of patients losing 3 or more lines of visual acuity
percentage of patients gaining 3 or more lines of visual acuity
mean change from baseline in visual acuity
OCT evidence of active CNV leakage
fluorescein angiographic evidence of active CNV leakage
number of retreatments

Collaborators and Investigators

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

Sponsor

Retinal Consultants Medical Group

Investigators

  • Principal Investigator: Joel A Pearlman, M.D., Ph. D., Retinal Consultants Medical Group, Inc.

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

April 1, 2006

Study Registration Dates

First Submitted

January 24, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 26, 2007

Study Record Updates

Last Update Posted (Estimate)

January 26, 2007

Last Update Submitted That Met QC Criteria

January 25, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ComB-V001

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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