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

This study has been completed.

First Received: January 24, 2007 Last Updated: January 25, 2007 History of Changes

Sponsored by:	Retinal Consultants Medical Group
Information provided by:	Retinal Consultants Medical Group
ClinicalTrials.gov Identifier:	NCT00426998

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Pharmacodynamics Study
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:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Verteporfin Bevacizumab

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:

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

Exclusion Criteria:

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.
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.
Patients who use medications that may induce photosensitivity.
Patients who have undergone YAG capsulotomy within the last month.
Subjects currently involved in any experimental procedure within the last 12 weeks.
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

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

Keywords provided by Retinal Consultants Medical Group:

Choroidal neovascularization due to age-related macular degeneration

Study placed in the following topic categories:

Uveal Diseases
Eye Diseases
Choroid Diseases
Verteporfin
Macular Degeneration
Retinal Degeneration
Bevacizumab
Angiogenesis Inhibitors

Choroidal Neovascularization
Photosensitizing Agents
Radiation-Sensitizing Agents
Metaplasia
Neoplasm Metastasis
Neovascularization, Pathologic
Retinal Diseases

Additional relevant MeSH terms:

Uveal Diseases
Antineoplastic Agents
Growth Substances
Eye Diseases
Physiological Effects of Drugs
Choroid Diseases
Verteporfin
Macular Degeneration
Retinal Degeneration
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions

Choroidal Neovascularization
Photosensitizing Agents
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Metaplasia
Growth Inhibitors
Angiogenesis Modulating Agents
Neovascularization, Pathologic
Dermatologic Agents
Retinal Diseases

ClinicalTrials.gov processed this record on September 10, 2009