This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to their treatment assignment. The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
9
2.0 mg
0.5 mg
Vitreous Retina Macula Consultants of New York
New York, New York, United States
Mean Change in Visual Acuity (VA) From Baseline at Month 6
Time frame: Baseline and 6 months
Mean Change in Visual Acuity (VA) From Baseline at Month 12
* Mean change in Visual Acuity (VA) from Baseline at Month 12 * Mean change in central foveal thickness (RPE to ILM) as measured by SD-OCT (Spectralis HRA + OCT (Heidelberg Engineering, Heidelberg, Germany) at Months 6 and 12 * Mean change in leakage as determined by FA at Months 6 and 12 * Mean number of ranibizumab injections at Months 6 and 12 * Mean time to first re-treatment following the initial 3 monthly loading doses * Mean duration of fluid-free interval * Safety and tolerability of 2.0mg using the incidence and severity of adverse events
Time frame: one year
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