Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema - Full Text View

Sponsor:	Hospital Juarez de Mexico
Information provided by (Responsible Party):	Virgilio Lima Gomez, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier:	NCT00900887

Purpose

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	Intervention	Phase
Diabetic Retinopathy Macular Edema	Drug: Tromethamine ketorolac Drug: Nepafenac Drug: Polietilenglicol 400, propilenglicol, HP guar	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders

Drug Information available for: Ketorolac Ketorolac tromethamine Nepafenac Tromethamine

U.S. FDA Resources

Further study details as provided by Hospital Juarez de Mexico:

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 [ Time Frame: one week after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

center point thickness using stratus OCT measured in microns [ Time Frame: before treatment, at 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]
macular volume using stratus OCT measured in cubic millimeters [ Time Frame: before treatment, 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]
visual capacity under subjective refractive correction measured in decimal equivalent [ Time Frame: before treatment, at 24, 48, 168 hours after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Ketorolac ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation	Drug: Tromethamine ketorolac ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week Other Name: 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 Name: Nevanac
Placebo Comparator: Placebo ocular lubricant drops 3 times a day for a week after selective photocoagulation	Drug: Polietilenglicol 400, propilenglicol, HP guar 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 Name: Systane

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

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900887

Contacts

Contact: Virgilio Lima Gomez, MD, MSc	01 52 55 57 47 75 60 ext 7634	investigacionclinicahjm@yahoo.com.mx
Contact: Dulce M Razo Blanco Hernandez, MD	01 52 55 57 47 75 60 ext 7503	dulcerazo@yahoo.com.mx

Locations

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

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

More Information

No publications provided

Responsible Party:	Virgilio Lima Gomez, PhD, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier:	NCT00900887 History of Changes
Other Study ID Numbers:	HJM 1470/08.03.18
Study First Received:	May 11, 2009
Last Updated:	February 8, 2012
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection; United States: Federal Government

Keywords provided by Hospital Juarez de Mexico:

diabetic retinopathy
clinically significant macular edema
selective photocoagulation
topic ketorolac

topic nepafenac
efficacy
treatment

Additional relevant MeSH terms:

Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Anti-Inflammatory Agents

Ketorolac
Ketorolac Tromethamine
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012