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

Novartis1 site in 1 country202 target enrollmentJune 2003

ConditionsAge-Related Macular Degeneration

DrugsVerteporfin for injection

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Age-Related Macular Degeneration
Sponsor: Novartis
Enrollment: 202
Locations: 1
Primary Endpoint: visual acuity measurements, baseline, 12 months
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

TBD

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

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.

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