Photodynamic Therapy in Occult-Only Lesions (POOL)

Novartis202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

202

Conditions

Age-Related Macular Degeneration

Interventions

Verteporfin for injectionDRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

visual acuity measurements, baseline, 12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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