Photodynamic Therapy in Occult-Only Lesions (POOL)

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135837
• Other study ID #: CBPD952B2401
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2005
• Last updated: June 20, 2006
• Start date: June 2003

Study information

• Verified date: June 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Federal Ministry for Health and WomenFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthSpain: Ministry of Health and ConsumptionPortugal: National Pharmacy and Medicines InstitutePoland: Ministry of HealthUnited Kingdom: National Health ServiceFinland: Finnish Medicines AgencyDenmark: National Board of HealthSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration

Intervention

Drug:
• Verteporfin for injection

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	QLT Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity measurements, baseline, 12 months
Secondary	visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months