Photodynamic Therapy in Occult-Only Lesions (POOL) - Tabular View

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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

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.