Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Retinopathy, Macular Edema

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Nepafenac
* Drug: Polietilenglicol 400, propilenglicol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac<br>ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation | Drug: Ketorolac<br>* ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week<br>* Other names: Godek;|
| Active Comparator: Nepafenac<br>ocular topic nepafenac 3 times a day during one week after selective photocoagulation | Drug: Nepafenac<br>* topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week<br>* Other names: Nevanac;|
| Placebo Comparator: Polietilenglicol 400, propilenglicol<br>ocular lubricant drops 3 times a day for a week after selective photocoagulation | Drug: Polietilenglicol 400, propilenglicol<br>* 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<br>* Other names: Systane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation |  | one week after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| center point thickness using stratus OCT measured in microns |  | before treatment, at 24, 48 and 168 hours after treatment | 
| macular volume using stratus OCT measured in cubic millimeters |  | before treatment, 24, 48 and 168 hours after treatment | 
| visual capacity under subjective refractive correction measured in decimal equivalent |  | before treatment, at 24, 48, 168 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic retinopathy, clinically significant macular edema, selective photocoagulation, topic ketorolac, topic nepafenac, efficacy, treatment