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Photodynamic Therapy in Occult-Only Lesions (POOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135837
First Posted: August 26, 2005
Last Update Posted: June 21, 2006
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.
Collaborator:
QLT Inc.
Information provided by:
Novartis
  Purpose
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.

Condition Intervention Phase
Age-Related Macular Degeneration Drug: Verteporfin for injection Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • visual acuity measurements, baseline, 12 months

Secondary Outcome Measures:
  • visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months

Estimated Enrollment: 202
Study Start Date: June 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  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): NCT00135837


Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
QLT Inc.
Investigators
Study Chair: Novartis Customer Information Novartis
  More Information

ClinicalTrials.gov Identifier: NCT00135837     History of Changes
Other Study ID Numbers: CBPD952B2401
First Submitted: August 24, 2005
First Posted: August 26, 2005
Last Update Posted: June 21, 2006
Last Verified: June 2006

Keywords provided by Novartis:
Age related Macula Degeneration,
AMD,
choroidal neovascularisation (CNV),
occult CNV lesion,
verteporfin for injection,
photodynamic therapy (PDT)

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Verteporfin
Photosensitizing Agents
Dermatologic Agents