Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

NCT00900887 | Completed Phase 2

• 1 other identifier: HJM 1470/08.03.18
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Macular Edema

Keywords

diabetic retinopathy; clinically significant macular edema; selective photocoagulation; topic ketorolac; topic nepafenac; efficacy; treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Ketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac

Nepafenac

ACTIVE COMPARATOR

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

Drug: Nepafenac

Polietilenglicol 400, propilenglicol

PLACEBO COMPARATOR

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

Drug: Polietilenglicol 400, propilenglicol

Interventions

Ketorolac DRUG

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

Also known as: Godek

Ketorolac

Nepafenac DRUG

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

Also known as: Nevanac

Nepafenac

Polietilenglicol 400, propilenglicol 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

Also known as: Systane

Polietilenglicol 400, propilenglicol

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Virgilio Lima Gomez

Mexico City, Mexico City, 07760, Mexico

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema

Interventions

Ketorolac; nepafenac

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Virgilio Lima Gomez, MD, MSc

  Hospital Juarez de Mexico

  STUDY CHAIR

• Dulce M Razo Blanco Hernandez, MD

  Hospital Juarez de Mexico

  PRINCIPAL INVESTIGATOR

• Juan Asbun Bojalil, MD, PhD

  Hospital Juarez de Mexico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: April 1, 2008
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

ME (1)