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

This study has been completed.
Sponsor:
Information provided by:
Retinal Consultants Medical Group
ClinicalTrials.gov Identifier:
NCT00426998
First received: January 24, 2007
Last updated: January 25, 2007
Last verified: January 2007
History of Changes
  Purpose

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 Intervention Phase
Choroidal Neovascularization
Macular Degeneration
 Drug: Verteporfin
Drug: Bevacizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Factorial Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Retinal Consultants Medical Group:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: April 2006
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426998

Locations
United States, California
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States, 95819
Sponsors and Collaborators
Retinal Consultants Medical Group
Investigators
Principal Investigator: Joel A Pearlman, M.D., Ph. D. Retinal Consultants Medical Group, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00426998     History of Changes
Other Study ID Numbers: ComB-V001
Study First Received: January 24, 2007
Last Updated: January 25, 2007
Health Authority: United States: Food and Drug Administration

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
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 22, 2013