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

Macular Degeneration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426998
• Other study ID #: ComB-V001
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2007
• Last updated: January 25, 2007
• Start date: April 2006

Study information

• Verified date: January 2007
• Source: Retinal Consultants Medical Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• Verteporfin

• Bevacizumab

Locations

Country	Name	City	State
United States	Retinal Consultants Medical Group, Inc.	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Retinal Consultants Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients losing 3 or more lines of visual acuity
Primary	percentage of patients gaining 3 or more lines of visual acuity
Primary	mean change from baseline in visual acuity
Primary	OCT evidence of active CNV leakage
Primary	fluorescein angiographic evidence of active CNV leakage
Primary	number of retreatments