Evaluation of Dosing Interval of Higher Doses of Ranibizumab

Macular Degeneration Clinical Trial

— BGB/IST  

Official title:

Evaluation of Dosing Interval of Higher Doses of Ranibizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533520
• Other study ID #: FVF4155s
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2007
• Last updated: November 21, 2013
• Start date: September 2007
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Tennessee Retina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• ranibizumab
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

Locations

Country	Name	City	State
United States	Tennessee Retina, P.C.	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Brandon G. Busbee, MD	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection		24 months	Yes
Secondary	Injection interval: mean time and number of injections		24 months	No