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Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Information source: Hospital Juarez de Mexico
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Retinopathy; Macular Edema

Intervention: Ketorolac (Drug); Nepafenac (Drug); Polietilenglicol 400, propilenglicol (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hospital Juarez de Mexico

Official(s) and/or principal investigator(s):
Virgilio Lima Gomez, MD, MSc, Study Chair, Affiliation: Hospital Juarez de Mexico
Dulce M Razo Blanco Hernandez, MD, Principal Investigator, Affiliation: Hospital Juarez de Mexico
Juan Asbun Bojalil, MD, PhD, Study Director, Affiliation: Hospital Juarez de Mexico

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation

Secondary outcome:

center point thickness using stratus OCT measured in microns

macular volume using stratus OCT measured in cubic millimeters

visual capacity under subjective refractive correction measured in decimal equivalent

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

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Virgilio Lima Gomez, Mexico, Distrito Federal 07760, Mexico
Additional Information

Starting date: April 2008
Last updated: March 18, 2015

Page last updated: August 23, 2015

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