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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426998
Recruitment Status : Completed
First Posted : January 26, 2007
Last Update Posted : January 26, 2007
Information provided by:
Retinal Consultants Medical Group

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Macular Degeneration Drug: Verteporfin Drug: Bevacizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : April 2006

Primary Outcome Measures :
  1. percentage of patients losing 3 or more lines of visual acuity
  2. percentage of patients gaining 3 or more lines of visual acuity
  3. mean change from baseline in visual acuity
  4. OCT evidence of active CNV leakage
  5. fluorescein angiographic evidence of active CNV leakage
  6. number of retreatments

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426998

United States, California
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States, 95819
Sponsors and Collaborators
Retinal Consultants Medical Group
Principal Investigator: Joel A Pearlman, M.D., Ph. D. Retinal Consultants Medical Group, Inc. Identifier: NCT00426998     History of Changes
Other Study ID Numbers: ComB-V001
First Posted: January 26, 2007    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007

Keywords provided by Retinal Consultants Medical Group:
Choroidal neovascularization due to age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents