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Evaluation of Dosing Interval of Higher Doses of Ranibizumab

NCT ID: NCT00533520

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Macular Degeneration Choroidal Neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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rhuFab V2

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Brandon G. Busbee, MD

OTHER

Sponsor Role lead

Responsible Party

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Brandon G. Busbee, MD

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brandon G Busbee, MD

Role: PRINCIPAL_INVESTIGATOR

Tennessee Retina, P.C,.

Locations

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Tennessee Retina, P.C.

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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FVF4155s

Identifier Type: -

Identifier Source: org_study_id