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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.

Tracking Information
First Submitted Date  ICMJE April 29, 2009
First Posted Date  ICMJE May 1, 2009
Results First Submitted Date  ICMJE September 18, 2012
Results First Posted Date  ICMJE January 18, 2013
Last Update Posted Date January 18, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2009)
Mean change from baseline in best corrected visual acuity (BCVA) [ Time Frame: Month 12 ]
Change History Complete list of historical versions of study NCT00891735 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Number of Ranibizumab Injections up to But Not Including Month 12 [ Time Frame: 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2009)
  • Mean number of ranibizumab injections up to and including Month 12 [ Time Frame: Up to 12 months ]
  • Proportion of patients who gain ≥ 15 letters in BCVA at 12 months compared with baseline [ Time Frame: 12 months ]
  • Proportion of patients with BCVA of 20/40 or better at baseline and Month 12 [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age-related Macular Degeneration
Intervention  ICMJE Drug: Ranibizumab
Sterile solution for intravitreal injection.
Other Name: Lucentis
Study Arms  ICMJE
  • Experimental: Ranibizumab 0.5 mg monthly
    Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
    Intervention: Drug: Ranibizumab
  • Experimental: Ranibizumab 2.0 mg monthly
    Patients received ranibizumab 2.0 mg monthly administered intravitreally for 24 months.
    Intervention: Drug: Ranibizumab
  • 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.
    Intervention: Drug: Ranibizumab
  • 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.
    Intervention: Drug: Ranibizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
1097
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2009)
1100
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891735
Other Study ID Numbers  ICMJE FVF4579g
GX01511 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP