- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00570193
Photodynamic and Pharmacologic Treatment of CNV (PBS)
July 6, 2012 updated by: Mid-Atlantic Retina Consultations, Inc.
Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All previously untreated CNV secondary to MD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I
Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)
|
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:
|
Experimental: II
Treatment with ranibizumab (Lucentis)
|
ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33&37 per study protocol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual change
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of treatment
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nabil M Jabbour, MD, Mid-Atlantic Retina Consultations
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
December 6, 2007
First Submitted That Met QC Criteria
December 7, 2007
First Posted (Estimate)
December 10, 2007
Study Record Updates
Last Update Posted (Estimate)
July 10, 2012
Last Update Submitted That Met QC Criteria
July 6, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Uveal Diseases
- Choroid Diseases
- Metaplasia
- Macular Degeneration
- Choroidal Neovascularization
- Neovascularization, Pathologic
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Photosensitizing Agents
- Dermatologic Agents
- Ranibizumab
- Verteporfin
Other Study ID Numbers
- PBS-100-388
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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