This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.
This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (\>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment. Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment. Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
intravitreal injection
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, United States
Charlotte Eye Ear Nose and Throat Associates, PA
Statesville, North Carolina, United States
The primary outcome measure is mean change in ETDRS BCVA visual acuity
The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline.
Time frame: 24 weeks
Proportion of eyes that gain or lose >0 letters at 24 weeks
Proportion of eyes that gain or lose \>0 letters at 24 weeks
Time frame: 24 weeks
Proportion of eyes that gain or lose > 5 letters at 24 weeks
Proportion of eyes that gain or lose \> 5 letters at 24 weeks
Time frame: 24 weeks
Proportion of eyes that gain or lose > 10 letters at 24 weeks
Proportion of eyes that gain or lose \> 10 letters at 24 weeks
Time frame: 24 weeks
Proportion of eyes that gain or lose > 15 letters at 24 weeks
Proportion of eyes that gain or lose \> 15 letters at 24 weeks
Time frame: 24 weeks
To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting
To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting
Time frame: 24 weeks
• Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks
• Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks
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Time frame: 24 weeks