A Phase 4 interventional study of Ranibizumab in Diabetic Macular Edema, sponsored by Federal University of São Paulo. Withdrawn at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment
To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.
136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.
Browse Ganglion Cysts studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Drug: Ranibizumab
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).
Also known as: Lucentis
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
assess adverse events
To assess adverse events during the twelve months of the study.
Time frame: monthly, from Month 1 to Month 12
This study is withdrawn, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo