Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Hospital Juarez de Mexico

Status and phase: Completed; Phase 2

Conditions: Macular Edema; Diabetic Retinopathy

Treatments: Drug: Ketorolac; Drug: Polietilenglicol 400, propilenglicol; Drug: Nepafenac

Study type: Interventional

Funder types: Other

Identifiers

NCT00900887

HJM 1470/08.03.18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 3 patient groups, including a placebo group

Ketorolac

Active Comparator group

Description:

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

Treatment:

Drug: Ketorolac

Nepafenac

Active Comparator group

Description:

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

Treatment:

Drug: Nepafenac

Polietilenglicol 400, propilenglicol

Placebo Comparator group

Description:

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

Treatment:

Drug: Polietilenglicol 400, propilenglicol