Age-Related Macular Degeneration
Conditions
Keywords
Age related Macula Degeneration,, AMD,, choroidal neovascularisation (CNV),, occult CNV lesion,, verteporfin for injection,, photodynamic therapy (PDT)
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.
Interventions
DRUGVerteporfin for injection
Sponsors
QLT Inc.
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity measurements, baseline, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| visual acuity measurements, fundus photographs and fluorescein angiography at baseline, 12 months; ophthalmic examinations, adverse events, vital signs, concomitant medications, 12 months | — |
Countries
Switzerland
Outcome results
None listed