Evaluation of Dosing Interval of Higher Doses of Ranibizumab

Phase 4

Completed

• Conditions: Choroidal Neovascularization; Macular Degeneration
• Interventions: Drug: ranibizumab

• Registration Number: NCT00533520
• Lead Sponsor: Brandon G. Busbee, MD

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-21
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5mg ranibizumab	ranibizumab	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.
1.0mg ranibizumab	ranibizumab	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.
2.0mg ranibizumab	ranibizumab	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.

Primary Outcome Measures

Name	Time	Method
Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection	24 months

Secondary Outcome Measures

Name	Time	Method
Injection interval: mean time and number of injections	24 months

Trial Locations

Locations (1)

Tennessee Retina, P.C.; 🇺🇸 Nashville, Tennessee, United States