Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

This study is currently recruiting participants.

Verified March 2010 by Hospital Juarez de Mexico

Sponsor:

Information provided by (Responsible Party):

Virgilio Lima Gomez, Hospital Juarez de Mexico

ClinicalTrials.gov Identifier:

NCT00907114

First received: May 19, 2009

Last updated: December 4, 2012

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 19, 2009

Last Updated Date

December 4, 2012

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

center subfield mean thickness using Stratus OCT measured in microns [ Time Frame: baseline, 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00907114 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

center point thickness using Stratus OCT, measured in microns [ Time Frame: baseline, 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]
macular volume using Stratus OCT, measured in cubic millimeters [ Time Frame: baseline, 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

Official Title ^ICMJE

Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy

Brief Summary

The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.

Detailed Description

Panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3 to 4 sessions within 2 weeks. This treatment reduces the incidence of severe visual loss in the long term. Nonetheless, it induces macular thickness that delays the conclusion of the treatment. This delay could coincide with vitreous hemorrhage which, in turn, may limit additional photocoagulation.

Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Proliferative Diabetic Retinopathy
Macular Edema

Intervention ^ICMJE

Drug: Ketorolac tromethamine
Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation

Other Name: Godek
Drug: Alcohol polivinilico
Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation

Other Name: Acuafil

Study Arm (s)

Active Comparator: Ketorolac tromethamine
ocular topic ketorolac used 4 times a day during a week after panphotocoagulation

Intervention: Drug: Ketorolac tromethamine
Placebo Comparator: Placebo
ocular lubricant drops 4 times a day during one week after panphotocoagulation

Intervention: Drug: Alcohol polivinilico

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

type 2 diabetes
proliferative diabetic retinopathy
without macular edema
adequate quality 6 mm fast macular map on the day of treatment
visual capacity under subjective refraction before treatment
signed of inform consent

Exclusion Criteria:

ocular surgery in the last 4 months
myopia over -6.00 diopters
allergy to ketorolac or non-steroids antiinflammatory
previous selective photocoagulation
using non-steroids antiinflammatory or immunomodulators
intraocular inflammatory
any retinal disease different from diabetic retinopathy
pregnancy
actual corneal disease
inadequate quality 6 mm fast macular map after the second visit
inconsistency after the second visit
adverse event of the drug
remove of the inform consent

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Mexico

Administrative Information

NCT Number ^ICMJE

NCT00907114

Other Study ID Numbers ^ICMJE

HJM 1667/09.03.24

Has Data Monitoring Committee

Responsible Party

Virgilio Lima Gomez, Hospital Juarez de Mexico

Study Sponsor ^ICMJE

Hospital Juarez de Mexico

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Hospital Juarez de Mexico

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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