A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Ranibizumab
Intervention description: Sterile solution for intravitreal injection.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1097.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Lucentis; AMD; Age-related macular degeneration; Subfoveal neovascular age-related macular degeneration; Wet AMD; Macular degeneration; Ranibizumab

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.
    

Eligibility 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).