Photodynamic and Pharmacologic Treatment of CNV (PBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00570193
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):
Mid-Atlantic Retina Consultations, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Macular Degeneration Drug: verteporfin (Visudyne) Drug: ranibizumab (Lucentis) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)
Study Start Date : December 2006
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: I
Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)
Drug: verteporfin (Visudyne)
Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1
Other Names:
  • Visudyne = verteporfin
  • Lucentis = ranibizumab

Experimental: II
Treatment with ranibizumab (Lucentis)
Drug: ranibizumab (Lucentis)
ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33&37 per study protocol
Other Name: Lucentis = ranibizumab

Primary Outcome Measures :
  1. Visual change [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Frequency of treatment [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All previously untreated CNV secondary to MD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00570193

Sponsors and Collaborators
Mid-Atlantic Retina Consultations, Inc.
Principal Investigator: Nabil M Jabbour, MD Mid-Atlantic Retina Consultations

Responsible Party: Mid-Atlantic Retina Consultations, Inc. Identifier: NCT00570193     History of Changes
Other Study ID Numbers: PBS-100-388
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents