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
Overview
- Phase
- Phase 3
- Intervention
- Ranibizumab
- Conditions
- Age-related Macular Degeneration
- Sponsor
- Genentech, Inc.
- Enrollment
- 1097
- Primary Endpoint
- Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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
- •Treatment with Visudyne(R) in the non-study eye \< 7 days preceding Day
- •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.
Arms & Interventions
Ranibizumab 0.5 mg monthly
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
Intervention: Ranibizumab
Ranibizumab 2.0 mg monthly
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 24 months.
Intervention: Ranibizumab
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: Ranibizumab
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: Ranibizumab
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Ranibizumab Injections up to But Not Including Month 12(Baseline to Month 12)
- Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12(Baseline to Month 12)
- Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12(Month 12)
- Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12(Month 12)
- Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12(Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12)
- Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12(Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12)
- Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12(Baseline to Month 12)