NCT00900887

Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Hospital Juarez de Mexico · Other Government
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Retinopathy
• Macular Edema

Interventions

Type	Name	Description
DRUG	Ketorolac	ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week
DRUG	Nepafenac	topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week
DRUG	Polietilenglicol 400, propilenglicol	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

Timeline

• Start date: 2008-04-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2009-05-13
• Last updated: 2015-03-20

Locations

1 site across 1 country: Mexico