Macular Degeneration Clinical Trial
Official title:
A Phase I/II Open Label, Multicenter Study of the Safety, Tolerability and Efficacy of Multiple Intravitreal Injections of (Super-dose Anti-VEgf SAVE Trial) 2.0mg Ranibizumab in Subjects With Chronic Fluid on OCT Post Multiple Injections With Ranibizumab
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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