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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)
This study is ongoing, but not recruiting participants.

First Received on April 29, 2009.   Last Updated on March 28, 2012   History of Changes
Sponsor: Genentech
Information provided by (Responsible Party): Genentech
ClinicalTrials.gov Identifier: NCT00891735
  Purpose

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 CNV secondary to AMD.


Condition Intervention Phase
Macular Degeneration
Drug: ranibizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Mean change from baseline in best corrected visual acuity (BCVA) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean number of ranibizumab injections up to and including Month 12 [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients who gain â¿¥ 15 letters in BCVA at 12 months compared with baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients with BCVA of 20/40 or better at baseline and Month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 1095
Study Start Date: April 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: ranibizumab
0.5 mg monthly intravitreal dose
Experimental: 2 Drug: ranibizumab
2.0 mg monthly intravitreal dose
Experimental: 3 Drug: ranibizumab
0.5 mg as needed intravitreal dose
Experimental: 4 Drug: ranibizumab
2.0 mg as needed intravitreal dose

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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)

  • CNV lesions with classic CNV component, occult CNV, or with some classic CNV component are permissible.

Exclusion Criteria:

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Prior treatment with Visudyne(R), external-beam radiation therapy, or TTT in the study eye
  • Previous intravitreal drug delivery (e.g., 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. 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 (e.g., 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891735

  Show 99 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00891735     History of Changes
Other Study ID Numbers: FVF4579g, GX01511
Study First Received: April 29, 2009
Last Updated: March 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Lucentis
AMD
Age-Related Macular Degeneration
Subfoveal Neovascular Age-Related Macular Degeneration
Wet AMD
Macular degeneration
Ranibizumab

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2012