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Photodynamic and Pharmacologic Treatment of CNV (PBS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mid-Atlantic Retina Consultations, Inc.
ClinicalTrials.gov Identifier:
NCT00570193
First received: December 6, 2007
Last updated: July 6, 2012
Last verified: July 2012
  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: Double Blind (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 6, 2007
Last Updated: July 6, 2012

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

ClinicalTrials.gov processed this record on June 28, 2017