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

Sponsor

Retinal Consultants Medical Group (Other)

Overall Status

Completed

CT.gov ID

NCT00426998

Collaborator

(none)

Enrollment

Location

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Choroidal Neovascularization Macular Degeneration	Drug: Verteporfin Drug: Bevacizumab	Phase 2

Study Design

Study Type:

Interventional

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 :

Apr 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.