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Photodynamic and Pharmacologic Treatment of CNV (PBS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00570193
First Posted: December 10, 2007
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Mid-Atlantic Retina Consultations, Inc.
  Purpose
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 Intervention Phase
Choroidal Neovascularization Macular Degeneration Drug: verteporfin (Visudyne) Drug: ranibizumab (Lucentis) Phase 1 Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Mid-Atlantic Retina Consultations, Inc.:

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

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

Enrollment: 41
Study Start Date: December 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • All previously untreated CNV secondary to MD
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00570193


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

Responsible Party: Mid-Atlantic Retina Consultations, Inc.
ClinicalTrials.gov Identifier: NCT00570193     History of Changes
Other Study ID Numbers: PBS-100-388
First Submitted: December 6, 2007
First Posted: December 10, 2007
Last Update Posted: October 12, 2017
Last Verified: July 2012

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