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OpenTrials
Completed

NCT Number: NCT00900887

Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virgilio Lima Gomez

Mexico City, 07760, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

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

Nepafenac

Drug

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

Polietilenglicol 400, propilenglicol

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. center point thickness using stratus OCT measured in microns

    Time frame: before treatment, at 24, 48 and 168 hours after treatment

  2. macular volume using stratus OCT measured in cubic millimeters

    Time frame: before treatment, 24, 48 and 168 hours after treatment

  3. visual capacity under subjective refractive correction measured in decimal equivalent

    Time frame: before treatment, at 24, 48, 168 hours after treatment

Sponsors and collaborators

Lead sponsor

Hospital Juarez de Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
May 13, 2009
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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