Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (LADDER)
Status and phase
Completed
Phase 2
Conditions
Macular Degeneration
Treatments
Drug: Ranibizumab
Details and patient eligibility
About
This is a Phase II multicenter, dose-ranging, randomized, active treatment (monthly ITV injection)-controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in participants with subfoveal neovascular age-related macular degeneration (nAMD).
Enrollment
225 patients
Sex
All
Ages
50+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Newly diagnosed with wet AMD within 9 months of screening visit
- Participant must have received at least 2 prior ITV anti-vascular endothelial growth factor (VEGF) injections. However, the most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit
- Demonstrated response to prior ITV anti-VEGF treatment
- Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/20-20/200 Snellen equivalent
Exclusion criteria
- Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
- Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit
- History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD in the study eye
- Prior participation in a clinical trial involving anti-angiogenic drugs, other than ranibizumab, in either eye within 2 months of the randomization visit
- Subretinal hemorrhage in the study eye that involves the center of the fovea
- Subfoveal fibrosis, or atrophy in the study eye
- Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
- Uncontrolled ocular hypertension or glaucoma in the study eye
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye
- Uncontrolled blood pressure
- Uncontrolled atrial fibrillation within 3 months of informed consent
- History of myocardial infarction or stroke within the last 3 months prior to informed consent
- 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 of ranibizumab or placement of the Implant, that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications
- Use of oral corticosteroids
- Current treatment for any active systemic infection
- Use of anticoagulants, anti-platelets (other than aspirin), or medications known to exert similar effects
- Active malignancy within 12 months of randomization
- History of allergy to fluorescein
- Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
225 participants in 4 patient groups
Port Delivery System with Ranibizumab 10mg/mL
Experimental group
Description:
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
Treatment:
Drug: Ranibizumab
Port Delivery System with Ranibizumab 40mg/mL
Experimental group
Description:
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
Treatment:
Drug: Ranibizumab
Port Delivery System with Ranibizumab 100mg/mL
Experimental group
Description:
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
Treatment:
Drug: Ranibizumab
Intravitreal Injection with Ranibizumab 0.5mg
Active Comparator group
Description:
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
Treatment:
Drug: Ranibizumab
Trial contacts and locations
50
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Data sourced from clinicaltrials.gov
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