Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Sponsor

Hospital Juarez de Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT00900887

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy Macular Edema	Drug: Ketorolac Drug: Nepafenac Drug: Polietilenglicol 400, propilenglicol	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Ketorolac

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

Drug: Ketorolac

ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week

Other Names:

Godek

Active Comparator: Nepafenac

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

Drug: Nepafenac

topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week

Other Names:

Nevanac

Placebo Comparator: Polietilenglicol 400, propilenglicol

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

Drug: Polietilenglicol 400, propilenglicol

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

Other Names:

Systane

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virgilio Lima Gomez	Mexico	Distrito Federal	Mexico	07760

Sponsors and Collaborators

Hospital Juarez de Mexico

Investigators

Study Chair: Virgilio Lima Gomez, MD, MSc, Hospital Juarez de Mexico
Principal Investigator: Dulce M Razo Blanco Hernandez, MD, Hospital Juarez de Mexico
Study Director: Juan Asbun Bojalil, MD, PhD, Hospital Juarez de Mexico