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

Tracking Information

First Received Date ^ICMJE

August 24, 2005

Last Updated Date

June 20, 2006

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

visual acuity measurements, baseline, 12 months

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00135837 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Photodynamic Therapy in Occult-Only Lesions (POOL)

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Age-Related Macular Degeneration

Intervention ^ICMJE

Drug: Verteporfin for injection

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

202

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00135837

Responsible Party

Study ID Numbers ^ICMJE

CBPD952B2401

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

QLT Inc

Investigators ^ICMJE

Study Chair:

Novartis Customer Information

Novartis

Information Provided By

Novartis

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP