Phase 3
N=1,097
A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)
Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00891735 ↗Enrolled (actual)
1,097
Serious AEs
21.1%
Results posted
Jan 2013
Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 — 10.1; 9.2; 8.2; 8.6 Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranibizumab (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 |
10.1; 9.2; 8.2; 8.6 | — |
| SECONDARY Number of Ranibizumab Injections up to But Not Including Month 12 |
11.3; 11.2; 7.7; 6.9 | — |
| SECONDARY Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12 |
34.5; 36.1; 30.2; 33.0 | — |
| SECONDARY Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12 |
52.4; 50.0; 46.2; 43.6 | — |
| SECONDARY Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12 |
5.1; 5.8; 2.9; 4.8 | — |
| SECONDARY Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 |
-104.9; -84.9; -103.5; -100.6; -141.5; -128.6 | — |
| SECONDARY Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 |
-0.79; -0.80; -0.72; -0.81; -1.26; -1.30 | — |
| SECONDARY Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12 |
-2.14; -2.42; -1.74; -1.98; -2.35; -2.63 | — |
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 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).
Data sourced from ClinicalTrials.gov (NCT00891735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.