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

Retinal Consultants Medical Group

Status and phase: Completed; Phase 2

Conditions: Choroidal Neovascularization; Macular Degeneration

Treatments: Drug: Bevacizumab; Drug: Verteporfin

Study type: Interventional

Funder types: Other

Identifiers

NCT00426998

ComB-V001

Details and patient eligibility

About

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).

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)