Back to resultsCombination Bevacizumab and Verteporfin (Two Different Sequences of Treatment)in Neovascular AMD
Primary Purpose
Choroidal Neovascularization, Macular Degeneration
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Verteporfin
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Choroidal Neovascularization focused on measuring Choroidal neovascularization due to age-related macular degeneration
Eligibility 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.
-
Sites / Locations
- Retinal Consultants Medical Group, Inc.
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00426998
First Posted
January 24, 2007
Last Updated
January 25, 2007
Sponsor
Retinal Consultants Medical Group
1. Study Identification
Unique Protocol Identification Number
NCT00426998
Brief Title
Combination Bevacizumab and Verteporfin (Two Different Sequences of Treatment)in Neovascular AMD
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 Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Retinal Consultants Medical Group
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Macular Degeneration
Keywords
Choroidal neovascularization due to age-related macular degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Verteporfin
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Primary Outcome Measure Information:
Title
percentage of patients losing 3 or more lines of visual acuity
Title
percentage of patients gaining 3 or more lines of visual acuity
Title
mean change from baseline in visual acuity
Title
OCT evidence of active CNV leakage
Title
fluorescein angiographic evidence of active CNV leakage
Title
number of retreatments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel A Pearlman, M.D., Ph. D.
Organizational Affiliation
Retinal Consultants Medical Group, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retinal Consultants Medical Group, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combination Bevacizumab and Verteporfin (Two Different Sequences of Treatment)in Neovascular AMD
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