Trial | NCT00900887  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    84
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.
Study Started
Apr 30
2008
Primary Completion
Mar 31
2015
Study Completion
Mar 31
2015
Last Update
Mar 20
2015
Estimate

Drug Ketorolac

ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week

  • Other names: Godek

Drug Nepafenac

topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week

  • Other names: Nevanac

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

  • Other names: Systane

Ketorolac Active Comparator

ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation

Nepafenac Active Comparator

ocular topic nepafenac 3 times a day during one week after selective photocoagulation

Polietilenglicol 400, propilenglicol Placebo Comparator

ocular lubricant drops 3 times a day for a week after selective photocoagulation

Criteria 

Inclusion Criteria:

type 2 diabetes
regardless of diabetes duration and retinopathy severity level
one or both eyes with focal clinically significant macular edema
treated with selective or focal photocoagulation
visual capacity under subjective refraction before treatment
adequate quality 6mm fast macular map on the day of photocoagulation
signed of inform consent

Exclusion Criteria:

ocular surgery in the last 4 months
previous selective photocoagulation
topic or systemic antiinflammatory therapy in the last week
allergic to antiinflammatory non-steroids therapy
lent contact used in tha last 2 days before photocoagulation
history of ocular trauma, ocular infection or lacrimal dysfunction in the last 3 months
history of uveitis or ocular inflammation in the last 12 months
any ocular external disease, infection or inflammatory process during evaluation
corneal abnormalities that could modify visual capacity per se
actual corneal disease
pregnancy
myopia over -6.00 diopters
any retinal disease different from diabetic retinopathy
adverse event of the drug
desert to pharmacology therapy after the second visit
no assistance after the second visit
inadequate quality 6mm fast macular map after the second visit
No Results Posted