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Photodynamic Therapy in Occult-Only Lesions (POOL)

This study has been completed.
Study NCT00135837.   Last updated on June 20, 2006.   Information provided by Novartis

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Descriptive Information Fields
Brief Title  Photodynamic Therapy in Occult-Only Lesions (POOL)
Official Title  An Open-Label, Multicenter, Phase 4 Study of the Effect of Verteporfin for Injection Therapy in Subjects With Occult With No Classic Choroidal NeoVascularization Secondary to Age-Related Macular Degeneration
Brief Summary

Age related macular degeneration is the leading cause of blindness for people over 50 in the western world. Blood vessels which start to grow form a lesion in the back of the eye. Verteporfin may stabilize the disease, by closing the blood vessels. This study will assess the efficacy and safety of verteporfin in patients with occult only lesions.

Detailed Description
Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  visual acuity measurements, baseline, 12 months
Secondary Outcome Measure  visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months
Condition  Age-Related Macular Degeneration
Intervention  Drug: Verteporfin for injection
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  202
Start Date  June 2003
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • 50 years or older
  • Must see better or equal to 34 letters (visual acuity)
  • Choroidal neovascularization (CNV) lesion must be occult only

Exclusion Criteria:

  • Evidence of classic CNV in the lesion
  • Prior treatment of disease in study eye
  • Have a history of moderate to severe hepatic impairment

Other protocol-defined exclusion criteria may apply.

Gender Both
Ages 50 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Switzerland
Administrative Information Fields
NCT ID  NCT00135837
Organization ID CBPD952B2401
Secondary IDs ††
Study Sponsor  Novartis
Collaborators †† QLT Inc
Investigators 
Study Chair:     Novartis Customer Information     Novartis    
Information Provided By Novartis
Verification Date June 2006
First Received Date  August 24, 2005
Last Updated Date June 20, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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