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

NCT ID: NCT00426998

Last Updated: 2007-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Choroidal Neovascularization Macular Degeneration

Keywords

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Choroidal neovascularization due to age-related macular degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Verteporfin

Intervention Type DRUG

Bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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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Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Retinal Consultants Medical Group

OTHER

Sponsor Role lead

Principal Investigators

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Joel A Pearlman, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Retinal Consultants Medical Group, Inc.

Locations

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Retinal Consultants Medical Group, Inc.

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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ComB-V001

Identifier Type: -

Identifier Source: org_study_id