Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Condition(s) targeted: Diabetic Retinopathy; Macular Edema

Intervention: Tromethamine ketorolac (Godek) (Drug); Nepafenac (Nevanac) (Drug); Polietilenglicol 400, propilenglicol, HP guar (systane) (Drug)

Phase: Phase 2

Status: Recruiting

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

Overall contact:
Virgilio Lima Gomez, MD, MSc, Phone: 01 52 55 57 47 75 60, Ext: 7634, Email: investigacionclinicahjm@yahoo.com.mx

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

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

Virgilio Lima Gomez, MD, MSc, Phone: 01 52 55 57 47 75 60, Ext: 7634, Email: investigacionclinicahjm@yahoo.com.mx

Virgilio Lima Gomez, Mexico, Distrito Federal 07760, Mexico; Recruiting
Virgilio Lima Gomez, MD, MSc, Phone: 01 52 55 57 47 75 60, Ext: 7634, Email: investigacionclinicahjm@yahoo.com.mx
Dulce M Razo Blanco Hernandez, MD, Phone: 01 52 55 57 47 75 60, Ext: 7503, Email: dulcerazo@yahoo.com.mx
Virgilio Lima Gomez, MD, MSc, Principal Investigator
Dulce M Razo Blanco Hernandez, MD, Principal Investigator
Juan Asbun Bojalil, MD, PhD, Principal Investigator

Starting date: April 2008
Ending date: February 2010
Last updated: May 12, 2009