Dry AMD
Conditions
Keywords
AMD, Dry AMD, Drusen, CNV
Brief summary
A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.
Interventions
DRUGAnecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg
One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals.
One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dry AMD study eye, Wet AMD non-study eye. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Age * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48 | Month 48 | ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site. |
Countries
United States
Outcome results
None listed