Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)

Brandon G. Busbee, MD

Status and phase: Completed; Phase 4

Conditions: Choroidal Neovascularization; Macular Degeneration

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00533520

FVF4155s

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 50 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

37 participants in 3 patient groups

0.5mg ranibizumab

Active Comparator group

Description:

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.

Treatment:

Drug: ranibizumab

1.0mg ranibizumab

Active Comparator group

Description:

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.

Treatment:

Drug: ranibizumab

2.0mg ranibizumab

Active Comparator group

Description:

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.

Treatment:

Drug: ranibizumab