NCT00907114

Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Hospital Juarez de Mexico · Other Government
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.

Detailed description

Panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3 to 4 sessions within 2 weeks. This treatment reduces the incidence of severe visual loss in the long term. Nonetheless, it induces macular thickness that delays the conclusion of the treatment. This delay could coincide with vitreous hemorrhage which, in turn, may limit additional photocoagulation. Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient.

Conditions

• Proliferative Diabetic Retinopathy
• Macular Edema

Interventions

Type	Name	Description
DRUG	Ketorolac tromethamine	Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation
DRUG	Polivynilic alcohol	Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation

Timeline

• Start date: 2009-06-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2009-05-22
• Last updated: 2015-03-20

Locations

1 site across 1 country: Mexico