Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virgilio Lima Gomez, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier:
NCT00907114
First received: May 19, 2009
Last updated: March 18, 2015
Last verified: March 2015

May 19, 2009
March 18, 2015
June 2009
March 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00907114 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy
Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Proliferative Diabetic Retinopathy
  • Macular Edema
  • 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: 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
  • Active Comparator: Ketorolac tromethamine
    ocular topic ketorolac used 4 times a day during a week after panphotocoagulation
    Intervention: Drug: Ketorolac tromethamine
  • Placebo Comparator: Polivynilic alcohol
    ocular lubricant drops 4 times a day during one week after panphotocoagulation
    Intervention: Drug: Polivynilic alcohol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00907114
HJM 1667/09.03.24
No
Virgilio Lima Gomez, Hospital Juarez de Mexico
Hospital Juarez de Mexico
Not Provided
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
Hospital Juarez de Mexico
March 2015

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