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Completed

NCT Number: NCT00533520

Evaluation of Dosing Interval of Higher Doses of Ranibizumab

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

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Key information

Conditions

Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tennessee Retina, P.C.

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

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

Other names: rhuFab V2

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

Sponsors and collaborators

Lead sponsor

Brandon G. Busbee, MD

Other

Collaborators

  • Genentech, Inc.

Registry information

Acronym: BGB/IST

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2007
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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