The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the treatment of recurrent fluid.
This is an open-label, Phase I/II study of intravitreally administered 2.0 mg ranibizumab in subjects with persistent fluid or recurrent fluid on OCT after having received at least nine ranibizumab injections in the past twelve months. Consented, enrolled subjects will receive have monthly ETDRS BCVA, ophthalmic examination and OCTs evaluation using Stratus, Cirrus and Spectralis machines. Fluorescein angiography and autofluorescence will be done at BSL, and Months 6 and 12. DNA samples for genetic analysis will be collected at baseline. Subjects will receive open-label intravitreal injections of 2.0 mg ranibizumab administered every 28 days for 3 months: Following the three loading doses, all patients will receive a minimum "capped" PRN treatment (all patients will receive 2.0 mg intravitreal ranibizumab quarterly). Dosing should not occur earlier than 22 days after the previous treatment. Study visits should be scheduled to occur every 30 (±7) days relative to the date of the first injection (Day 0). Subjects will be randomized into two re-treatment cohorts for additional re-treatment, if needed: * Cohort A - Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal ,or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. * Cohort B - Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal ,or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Intravitreal Injection of 2.0mg formulation
Greater Houston Retina Research
Houston, Texas, United States
Greater Houston Retina Research
The Woodlands, Texas, United States
Mean Change From Baseline in ETDRS BCVA at Month 12 (Fixed Interval Dosing Primary Endpoint After 3 Monthly Doses. Variable Interval Dosing Primary Endpoint at 1 Year.)
Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS BCVA) was used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time frame: 1 Year
Evaluate the Incidence and Severity of Ocular and Non-ocular Adverse Events (AEs) Through Month 12
Time frame: 1 year
Determine Number of Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12 and Month 12 in ETDRS BCVA
Time frame: 1 year
Determine Number of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12 in ETDRS BCVA.
Time frame: 1 year
Evaluate Mean Change in Central Retinal Thickness Over Time Through Month12 as Assessed by All Three OCTs (Stratus, Cirrus, and Spectralis)
Time frame: 1 year
Assess Number of Ranibizumab Injections in Each of the Two Doses Required Through Month 12
Time frame: 1 year
Evaluate the Relationship Between Specific Genetic Polymorphisms Associated With AMD, Disease Characteristics and Processes, and Response to Intravitreal Ranibizumab
Time frame: 1 year
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