To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.
* Ranibizumab can be a safe treatment for diabetic macular edema regarding maintenance of retinal ganglion cell function after repeated intravitreal injections. * To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function. * The primary endpoint for the study will be the changes in full-field and focal macular photopic negative response (PhRN) amplitude (in µV) over time, from baseline to month 12.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
monthly ranibizumab (0,5 mg injected intravitreally in a standard fashion) until maximum visual acuity (VA) is achieved and remains stable for three consecutive months (for a minimum of 3 initial injections).
Dept of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, São Paulo, Brazil
focal macular changes in full-field and photopic negative response (PhRN) amplitude (in µV)
The photopic negative response (PhNR) of the full-field cone electroretinograms (ERGs) is a functional indicator of retinal ganglion. The PhNR consists of a negative-going wave that follows the photopic cone b wave. The PhNR is selectively attenuated in patients with optic nerve disease and glaucoma, indicating that the PhNR can be an objective functional measure reflecting the sum of the total response of the retinal ganglion cells in the entire retina.
Time frame: at Baseline and Months 3, 6, 9, 12
The mean change in BCVA
The mean change in best corrected visual acuity (BCVA) from baseline to month 12
Time frame: monthly, from baseline to Month 12
the mean change in central macular thickness (CMT)
To assess the mean change in central macular thickness (CMT), measured in spectral-domain optical coherence tomography (SD-OCT) from baseline to month 12
Time frame: monthly, from baseline to Month 12
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