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

Conditions

• Age-related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab — DRUG
  Sterile solution for intravitreal injection.

Study Details

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.

Key Dates

First listed

May 1, 2009

Start date

Jul 31, 2009

Status verified

Dec 2012

Primary completion

Aug 31, 2011

Completion

Aug 31, 2012

Study Design

Enrollment

1,097 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ranibizumab 0.5 mg monthly
  Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
• Experimental: Ranibizumab 2.0 mg monthly
  Patients received ranibizumab 2.0 mg monthly administered intravitreally for 24 months.
• 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.
• 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.

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 [ Time Frame: Baseline to Month 12 ]

Locations (99)

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