Evaluation of Dosing Interval of Higher Doses of Ranibizumab

Study Overview
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Brief Summary
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Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).

Detailed Description
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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.

Official Title
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Evaluation of Dosing Interval of Higher Doses of Ranibizumab

Conditions
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Macular Degeneration, Choroidal Neovascularization

Intervention / Treatment
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* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.5mg ranibizumab<br>Subjects will be treated with 0.5mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment. | Drug: ranibizumab<br>* 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<br>* Other names: rhuFab V2;|
| Active Comparator: 1.0mg ranibizumab<br>Subjects will be treated with 1.0mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment. | Drug: ranibizumab<br>* 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<br>* Other names: rhuFab V2;|
| Active Comparator: 2.0mg ranibizumab<br>Subjects will be treated with 2.0 mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment. | Drug: ranibizumab<br>* 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<br>* Other names: rhuFab V2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection interval: mean time and number of injections |  | 24 months |