Photodynamic Therapy in Occult-Only Lesions (POOL)
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Verteporfin for injection
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Age related Macula Degeneration,, AMD,, choroidal neovascularisation (CNV),, occult CNV lesion,, verteporfin for injection,, photodynamic therapy (PDT)
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.
Sites / Locations
- Novartis
Outcomes
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
Full Information
NCT ID
NCT00135837
First Posted
August 24, 2005
Last Updated
June 20, 2006
Sponsor
Novartis
Collaborators
QLT Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00135837
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
QLT Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Age related Macula Degeneration,, AMD,, choroidal neovascularisation (CNV),, occult CNV lesion,, verteporfin for injection,, photodynamic therapy (PDT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
202 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Verteporfin for injection
Primary Outcome Measure Information:
Title
visual acuity measurements, baseline, 12 months
Secondary Outcome Measure Information:
Title
visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Customer Information
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Photodynamic Therapy in Occult-Only Lesions (POOL)
We'll reach out to this number within 24 hrs