Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 17, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Proliferative Diabetic Retinopathy
Macular Edema
Drug: Ketorolac tromethamine
Drug: Alcohol polivinilico
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Hospital Juarez de Mexico:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 44
Study Start Date: June 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Placebo
ocular lubricant drops 4 times a day during one week after panphotocoagulation
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907114

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: NCT00907114     History of Changes
Other Study ID Numbers: HJM 1667/09.03.24
Study First Received: May 19, 2009
Last Updated: February 17, 2014
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection
United States: Federal Government

Keywords provided by Hospital Juarez de Mexico:
proliferative diabetic retinopathy
macular edema
panphotocoagulation
topic ketorolac
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
Ketorolac Tromethamine
Ketorolac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 18, 2014