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

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ClinicalTrials.gov Identifier: NCT00891735
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Drug: Ranibizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1097 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: Lucentis


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of Ranibizumab Injections up to But Not Including Month 12 [ Time Frame: Baseline to Month 12 ]
  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891735


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Locations
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United States, Arizona
Phoenix, Arizona, United States, 85020
Tucson, Arizona, United States, 85704
United States, 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, 94107
San Francisco, California, United States, 94115
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
United States, Colorado
Aurora, Colorado, United States, 80045
Colorado Springs, Colorado, United States, 80909
Golden, Colorado, United States, 80401
United States, Connecticut
Danbury, Connecticut, United States, 06810
Hamden, Connecticut, United States, 06518
New Haven, Connecticut, United States, 06510
New London, Connecticut, United States, 06320
United States, 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
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Hawaii
Aiea, Hawaii, United States, 96701
United States, Illinois
Chicago, Illinois, United States, 60637
Oak Park, Illinois, United States, 60304
United States, Indiana
Indianapolis, Indiana, United States, 46290
United States, Kansas
Shawnee Mission, Kansas, United States, 66204
Wichita, Kansas, United States, 67214
United States, Kentucky
Lexington, Kentucky, United States, 40509
Paducah, Kentucky, United States, 42001
United States, Maine
Portland, Maine, United States, 04102
United States, Maryland
Baltimore, Maryland, United States, 21287
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02114
Worcester, Massachusetts, United States, 01605
United States, Michigan
Jackson, Michigan, United States, 49201
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, Missouri
Saint Louis, Missouri, United States, 63144
United States, Nebraska
Lincoln, Nebraska, United States, 68506
United States, Nevada
Las Vegas, Nevada, United States, 89144
United States, 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
United States, 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
United States, North Carolina
Asheville, North Carolina, United States, 28803
Charlotte, North Carolina, United States, 28210
United States, Ohio
Beachwood, Ohio, United States, 44122
Cincinnati, Ohio, United States, 45242
Columbus, Ohio, United States, 43212
United States, Oregon
Portland, Oregon, United States, 97210
United States, 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
United States, South Carolina
Greenville, South Carolina, United States, 29605
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, 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
United States, Utah
Salt Lake City, Utah, United States, 84107
United States, Virginia
Richmond, Virginia, United States, 23235
Virginia Beach, Virginia, United States, 23454
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
United States, Wyoming
Casper, Wyoming, United States, 82601
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00891735     History of Changes
Other Study ID Numbers: FVF4579g
GX01511 ( Other Identifier: Hoffmann-La Roche )
First Posted: May 1, 2009    Key Record Dates
Results First Posted: January 18, 2013
Last Update Posted: January 18, 2013
Last Verified: December 2012
Keywords provided by Genentech, Inc.:
Lucentis
AMD
Age-related macular degeneration
Subfoveal neovascular age-related macular degeneration
 Wet AMD
Macular degeneration
Ranibizumab
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents