Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

NCT ID: NCT00900887

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2015-03-31

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.

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.

Conditions

Diabetic Retinopathy; Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ketorolac

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

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

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

Nepafenac

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

Group Type: ACTIVE_COMPARATOR

Nepafenac

Intervention Type: DRUG

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

Polietilenglicol 400, propilenglicol

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

Group Type: PLACEBO_COMPARATOR

Polietilenglicol 400, propilenglicol

Intervention Type: DRUG

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

Interventions

Ketorolac

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

Intervention Type: DRUG

Nepafenac

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Godek; Nevanac; Systane

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Juarez de Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Virgilio Lima Gomez

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Virgilio Lima Gomez, MD, MSc

Role: STUDY_CHAIR

Hospital Juarez de Mexico

Dulce M Razo Blanco Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Juarez de Mexico

Juan Asbun Bojalil, MD, PhD

Role: STUDY_DIRECTOR

Hospital Juarez de Mexico

Locations

Virgilio Lima Gomez

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

HJM 1470/08.03.18

Identifier Type: -

Identifier Source: org_study_id