Photodynamic and Pharmacologic Treatment of CNV (PBS)

Mid-Atlantic Retina Consultations, Inc.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Choroidal Neovascularization; Macular Degeneration

Treatments: Drug: verteporfin (Visudyne); Drug: ranibizumab (Lucentis)

Study type: Interventional

Funder types: Other

Identifiers

NCT00570193

PBS-100-388

Details and patient eligibility

About

The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.

Enrollment: 41 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All previously untreated CNV secondary to MD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 2 patient groups

I

Experimental group

Description:

Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)

Treatment:

Drug: verteporfin (Visudyne)

II

Experimental group

Description:

Treatment with ranibizumab (Lucentis)

Treatment:

Drug: ranibizumab (Lucentis)