A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR) (HARBOR)

December 11, 2012 updated by: Genentech, Inc.

A Phase III, Double-masked, Multicenter, Randomized, Active Treatment-controlled Study of the Efficacy and Safety of 0.5 mg and 2.0 mg Ranibizumab Administered Monthly or on an As-needed Basis (PRN) in Patients With Subfoveal Neovascular Age-related Macular Degeneration

This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the efficacy and safety of ranibizumab injection administered intravitreally to patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Results are presented for the first 12 months of the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1097

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
      • Tucson, Arizona, United States, 85704
    • California
      • Arcadia, California, United States, 91007
      • Beverly Hills, California, United States, 90211
      • Campbell, California, United States, 95008
      • Chico, California, United States, 95973
      • La Jolla, California, United States, 92093-0946
      • Los Angeles, California, United States, 90033
      • Los Angeles, California, United States, 90095-7000
      • Mountain View, California, United States, 94040
      • Oakland, California, United States, 94609
      • Palm Desert, California, United States, 92211
      • Poway, California, United States, 92064
      • Sacramento, California, United States, 95817
      • San Francisco, California, United States, 94115
      • San Francisco, California, United States, 94107
      • Santa Ana, California, United States, 92705
      • Santa Barbara, California, United States, 93103
      • Torrance, California, United States, 90503
      • Ventura, California, United States, 93003
      • Westlake Village, California, United States, 91361
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Colorado Springs, Colorado, United States, 80909
      • Golden, Colorado, United States, 80401
    • Connecticut
      • Danbury, Connecticut, United States, 06810
      • Hamden, Connecticut, United States, 06518
      • New Haven, Connecticut, United States, 06510
      • New London, Connecticut, United States, 06320
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Boynton Beach, Florida, United States, 33426
      • Fort Lauderdale, Florida, United States, 33334
      • Fort Myers, Florida, United States, 33912
      • Palm Beach Gardens, Florida, United States, 33410
      • Pensacola, Florida, United States, 32503
      • Stuart, Florida, United States, 34994
      • Tampa, Florida, United States, 33609
      • Tampa, Florida, United States, 33612
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Hawaii
      • Aiea, Hawaii, United States, 96701
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Oak Park, Illinois, United States, 60304
    • Indiana
      • Indianapolis, Indiana, United States, 46290
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
      • Wichita, Kansas, United States, 67214
    • Kentucky
      • Lexington, Kentucky, United States, 40509
      • Paducah, Kentucky, United States, 42001
    • Maine
      • Portland, Maine, United States, 04102
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Hagerstown, Maryland, United States, 21740
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Boston, Massachusetts, United States, 02114
      • Worcester, Massachusetts, United States, 01605
    • Michigan
      • Jackson, Michigan, United States, 49201
    • Minnesota
      • Edina, Minnesota, United States, 55435
    • Missouri
      • Saint Louis, Missouri, United States, 63144
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
    • Nevada
      • Las Vegas, Nevada, United States, 89144
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
      • New Brunswick, New Jersey, United States, 08901
      • Northfield, New Jersey, United States, 08225
      • Teaneck, New Jersey, United States, 07666
      • Vauxhall, New Jersey, United States, 07088
    • New York
      • Great Neck, New York, United States, 11021
      • Lynbrook, New York, United States, 11563
      • New York, New York, United States, 10021
      • Rochester, New York, United States, 14620
      • Shirley, New York, United States, 11967
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Charlotte, North Carolina, United States, 28210
    • Ohio
      • Beachwood, Ohio, United States, 44122
      • Cincinnati, Ohio, United States, 45242
      • Columbus, Ohio, United States, 43212
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
      • Huntingdon Valley, Pennsylvania, United States, 19006
      • Johnstown, Pennsylvania, United States, 15904
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15212
      • Pittsburgh, Pennsylvania, United States, 15213
      • West Mifflin, Pennsylvania, United States, 15122
    • South Carolina
      • Greenville, South Carolina, United States, 29605
      • Ladson, South Carolina, United States, 29456
      • West Columbia, South Carolina, United States, 29169
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Abilene, Texas, United States, 79606
      • Austin, Texas, United States, 78705
      • Desoto, Texas, United States, 75115
      • Houston, Texas, United States, 77030
      • McAllen, Texas, United States, 78503
      • San Antonio, Texas, United States, 78240
      • Temple, Texas, United States, 76508
      • The Woodlands, Texas, United States, 77384
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • Virginia
      • Richmond, Virginia, United States, 23235
      • Virginia Beach, Virginia, United States, 23454
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
    • Wyoming
      • Casper, Wyoming, United States, 82601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.

Ocular Inclusion Criteria (Study Eye)

  • Best corrected visual acuity (BCVA), using Early Treatment Diabetic Retinopathy Study (ETDRS) charts, of 20/40-20/320 (Snellen equivalent).
  • Choroidal neovascularization (CNV) lesions with classic CNV component, occult CNV, or with some classic CNV component were permissible.
  • Total area of lesion < 12 disc area or 30.48 mm^2.

Exclusion Criteria:

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye.
  • Prior treatment with Visudyne(R), external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye.
  • Previous intravitreal drug delivery (eg, intravitreal corticosteroid injection, anti-angiogenic drugs, or device implantation) in the study eye.
  • Previous treatment or participation in a clinical trial involving anti-angiogenic drugs (Avastin(R), anecortave acetate, protein kinase C inhibitors, etc), in the non-study eye within 3 months of Day 0 (first day of treatment). The patient may not have received Lucentis(R) or Macugen(R) in the non-study eye within 7 days of Day 0.
  • Treatment with Visudyne(R) in the non-study eye < 7 days preceding Day 0.
  • Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc area (2.54 mm^2) in size.
  • Subfoveal fibrosis or atrophy in the study eye.
  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
  • Retinal pigment epithelial tear involving the macula in the study eye.
  • Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could either: Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition; or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity (BCVA) over the 24-month study period.
  • Uncontrolled blood pressure.
  • Atrial fibrillation not managed by patient's primary care physician or cardiologist within 3 months of screening visit.
  • History of stroke within the last 3 months of screening visit.
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.
  • Current treatment for active systemic infection.
  • Active malignancy.
  • History of allergy to fluorescein, not amenable to treatment.
  • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Ranibizumab 0.5 mg monthly
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
Drug: Ranibizumab
Sterile solution for intravitreal injection.
Other Names:
  • Lucentis
EXPERIMENTAL: Ranibizumab 2.0 mg monthly
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 24 months.
Drug: Ranibizumab
Sterile solution for intravitreal injection.
Other Names:
  • Lucentis
EXPERIMENTAL: Ranibizumab 0.5 mg as-needed (pro re nata [PRN])
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
Drug: Ranibizumab
Sterile solution for intravitreal injection.
Other Names:
  • Lucentis
EXPERIMENTAL: Ranibizumab 2.0 mg as-needed (pro re nata [PRN])
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Drug: Ranibizumab
Sterile solution for intravitreal injection.
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
Time Frame: Baseline to Month 12
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.
Baseline to Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Ranibizumab Injections up to But Not Including Month 12
Time Frame: Baseline to Month 12
Baseline to Month 12
Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12
Time Frame: Baseline to Month 12
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Baseline to Month 12
Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12
Time Frame: Month 12
VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.
Month 12
Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12
Time Frame: Month 12
The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness < 270 µm.
Month 12
Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Time Frame: Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).
Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Time Frame: Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).
Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12
Time Frame: Baseline to Month 12
The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm^2.
Baseline to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FVF4579g
  • GX01511 (OTHER: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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