A Phase 2 interventional study of Ketorolac and Nepafenac in Diabetic Retinopathy and Macular Edema, sponsored by Hospital Juarez de Mexico. Completed at 1 site in Mexico. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-20.
Sponsored by Hospital Juarez de Mexico · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the efficacy of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.
Selective photocoagulation is the standard treatment for clinically significant macular edema. This treatment decreased the incidence of moderate visual loss in the long term. Nonetheless, in the first six weeks after treatment it is induced, probably because an exacerbation of macular edema secondary to treatment. An inflammatory response has been reported after selective photocoagulation. Therefore, antiinflammatory therapy like ketorolac or nepafenac could be useful to manage center point thickness secondary to selective photocoagulation in diabetics with macular edema.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 84 is above the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Hospital Juarez de Mexico is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation
Drug: Ketorolac
ocular topic nepafenac 3 times a day during one week after selective photocoagulation
Drug: Nepafenac
ocular lubricant drops 3 times a day for a week after selective photocoagulation
Drug: Polietilenglicol 400, propilenglicol
ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week
Also known as: Godek
topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week
Also known as: Nevanac
ocular presentation Polietilenglicol 400 (4 mg), propilenglicol (3 mg), HP guar (1.9 mg)/1 ml dosage: one drop (0.2 mg polietinglicol 400, 0.15 mg propilenglicol, 0.095 mg HP guar) 3 times a day during one week
Also known as: Systane
ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation
Time frame: one week after treatment
center point thickness using stratus OCT measured in microns
Time frame: before treatment, at 24, 48 and 168 hours after treatment
macular volume using stratus OCT measured in cubic millimeters
Time frame: before treatment, 24, 48 and 168 hours after treatment
visual capacity under subjective refractive correction measured in decimal equivalent
Time frame: before treatment, at 24, 48, 168 hours after treatment
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Hospital Juarez de Mexico