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

Phase 2

Completed

• Conditions: Choroidal Neovascularization; Macular Degeneration

• Registration Number: NCT00426998
• Lead Sponsor: Retinal Consultants Medical Group

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Status Verified: 2007-01
• Study First Submitted: 2007-01-24
• Study First Submitted QC: 2007-01-25
• Last Update Submitted: 2007-01-25
• Study First Posted: 2007-01-26
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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-

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Retinal Consultants Medical Group, Inc.; 🇺🇸 Sacramento, California, United States