AMD
Conditions
Brief summary
The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.
Interventions
One 0.5 mL injection into the PJD at 6-month intervals for 42 months
One 0.5 mL injection into the PJD at 6-month intervals for 42 months
One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dry AMD in study eye, Wet AMD non-study eye. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Under 50. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye | Month 48 |
Secondary
| Measure | Time frame |
|---|---|
| Time to development of sight-threatening CNV | Timepoint |
Countries
India
Outcome results
None listed