Photodynamic Therapy in Occult-Only Lesions (POOL)
Phase 4
Completed
- Conditions
- Age-Related Macular Degeneration
- Registration Number
- NCT00135837
- Lead Sponsor
- Novartis
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method visual acuity measurements, baseline, 12 months
- Secondary Outcome Measures
Name Time Method visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland