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CompletedNCT00533520BGB/ISTUpdated Nov 25, 2013

Evaluation of Dosing Interval of Higher Doses of Ranibizumab

A Phase 4 interventional study of ranibizumab in Macular Degeneration and Choroidal Neovascularization, sponsored by Brandon G. Busbee, MD. Completed at 1 site in United States. Open to participants aged 50 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-25.

Sponsored by Brandon G. Busbee, MD · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
50 Years to 95 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Macular Degeneration
  • Choroidal Neovascularization
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 37 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

This is the only study on the registry with Brandon G. Busbee, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 95 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Pregnancy
  • Previous history of thromboembolic event including myocardial infarction or stroke
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    0.5mg 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.

    Drug: ranibizumab

  • Active comparator
    1.0mg 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.

    Drug: ranibizumab

  • Active comparator
    2.0mg 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.

    Drug: ranibizumab

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

    Also known as: rhuFab V2

06

What researchers measure

Primary outcomes

  1. Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection

    Time frame: 24 months

Secondary outcomes

  1. Injection interval: mean time and number of injections

    Time frame: 24 months

07

Study locations

1 site
  • Tennessee Retina, P.C.
    Nashville, Tennessee 37203, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00533520
Lead sponsor
Brandon G. Busbee, MD
Collaborators
Genentech, Inc.
Responsible party
Brandon G. Busbee, MD (Sponsor-Investigator, Tennessee Retina) — Sponsor-investigator
First posted
Sep 21, 2007
Start date
Sep 2007
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Nov 25, 2013

Study contacts

Brandon G Busbee, MD
principal investigator · Tennessee Retina, P.C,.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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