Clinical trial NCT00900887: Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema
Official title: Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Macular Edema
Keywords: diabetic retinopathy
clinically significant macular edema
selective photocoagulation
topic ketorolac
topic nepafenac
efficacy
treatment
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2009-05-13
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation
timeFrame: one week after treatment
Secondary outcomes:
measure: center point thickness using stratus OCT measured in microns
timeFrame: before treatment, at 24, 48 and 168 hours after treatment
measure: macular volume using stratus OCT measured in cubic millimeters
timeFrame: before treatment, 24, 48 and 168 hours after treatment
measure: visual capacity under subjective refractive correction measured in decimal equivalent
timeFrame: before treatment, at 24, 48, 168 hours after treatment
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Virgilio Lima Gomez
state: Distrito Federal
Study officials:
affiliation: Hospital Juarez de Mexico
name: Virgilio Lima Gomez, MD, MSc
role: STUDY_CHAIR
affiliation: Hospital Juarez de Mexico
name: Dulce M Razo Blanco Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Juarez de Mexico
name: Juan Asbun Bojalil, MD, PhD
role: STUDY_DIRECTOR
References: