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Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT00907114
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Virgilio Lima Gomez, Hospital Juarez de Mexico

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.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Macular Edema Drug: Ketorolac tromethamine Drug: Polivynilic alcohol Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy
Study Start Date : June 2009
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ketorolac tromethamine
ocular topic ketorolac used 4 times a day during a week after panphotocoagulation
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
Placebo Comparator: Polivynilic alcohol
ocular lubricant drops 4 times a day during one week after panphotocoagulation
Drug: Polivynilic alcohol
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



Primary Outcome Measures :
  1. center subfield mean thickness using Stratus OCT measured in microns [ Time Frame: baseline, 24, 48 and 168 hours after treatment ]

Secondary Outcome Measures :
  1. center point thickness using Stratus OCT, measured in microns [ Time Frame: baseline, 24, 48 and 168 hours after treatment ]
  2. macular volume using Stratus OCT, measured in cubic millimeters [ Time Frame: baseline, 24, 48 and 168 hours after treatment ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907114


Locations
Mexico
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

Responsible Party: Virgilio Lima Gomez, PhD, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier: NCT00907114     History of Changes
Other Study ID Numbers: HJM 1667/09.03.24
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015

Keywords provided by Virgilio Lima Gomez, Hospital Juarez de Mexico:
proliferative diabetic retinopathy
macular edema
panphotocoagulation
topic ketorolac
efficacy
treatment

Additional relevant MeSH terms:
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ethanol
Ketorolac
Ketorolac Tromethamine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action