Choroidal Neovascularization, Macular Degeneration
Conditions
Brief summary
Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).
Detailed description
Phase 4 study to test the safety, tolerability and effectiveness of a higher doses (1.0 mg and 2.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with age related macular degeneration who have never been treated with ranibizumab. An additional purpose is to determine if the higher doses (1.0 mg and 2.0 mg) of ranibizumab can increase the time between doses beyond that currently needed with the 0.5 mg dose.
Interventions
DRUGranibizumab
Arm A: 0.5 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Arm B: 1.0 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Third Arm 2.0mg Arm with retreatment based on defined criteria not to occur sooner than every 28 days
Sponsors
Genentech, Inc.
Brandon G. Busbee, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* Treatment naive macular degeneration patients with choroidal neovascularization * \>50 years old * Visual acuity 20/40 to 20/320
Exclusion criteria
* Pregnancy * Previous history of thromboembolic event including myocardial infarction or stroke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Injection interval: mean time and number of injections | 24 months |
Countries
United States
Outcome results
None listed