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 (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Choroidal Neovascularization
Macular Degeneration
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Uveal Diseases
Verteporfin
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014