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Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

Primary Purpose

Proliferative Diabetic Retinopathy, Macular Edema

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Ketorolac tromethamine
Polivynilic alcohol
Sponsored by
Hospital Juarez de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring proliferative diabetic retinopathy, macular edema, panphotocoagulation, topic ketorolac, efficacy, treatment

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virgilio Lima Gomez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketorolac tromethamine

Polivynilic alcohol

Arm Description

ocular topic ketorolac used 4 times a day during a week after panphotocoagulation

ocular lubricant drops 4 times a day during one week after panphotocoagulation

Outcomes

Primary Outcome Measures

center subfield mean thickness using Stratus OCT measured in microns

Secondary Outcome Measures

center point thickness using Stratus OCT, measured in microns
macular volume using Stratus OCT, measured in cubic millimeters

Full Information

First Posted
May 19, 2009
Last Updated
March 18, 2015
Sponsor
Hospital Juarez de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT00907114
Brief Title
Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy
Official Title
Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Juarez de Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy, Macular Edema
Keywords
proliferative diabetic retinopathy, macular edema, panphotocoagulation, topic ketorolac, efficacy, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac tromethamine
Arm Type
Active Comparator
Arm Description
ocular topic ketorolac used 4 times a day during a week after panphotocoagulation
Arm Title
Polivynilic alcohol
Arm Type
Placebo Comparator
Arm Description
ocular lubricant drops 4 times a day during one week after panphotocoagulation
Intervention Type
Drug
Intervention Name(s)
Ketorolac tromethamine
Other Intervention Name(s)
Godek
Intervention Description
Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation
Intervention Type
Drug
Intervention Name(s)
Polivynilic alcohol
Other Intervention Name(s)
Acuafil
Intervention Description
Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation
Primary Outcome Measure Information:
Title
center subfield mean thickness using Stratus OCT measured in microns
Time Frame
baseline, 24, 48 and 168 hours after treatment
Secondary Outcome Measure Information:
Title
center point thickness using Stratus OCT, measured in microns
Time Frame
baseline, 24, 48 and 168 hours after treatment
Title
macular volume using Stratus OCT, measured in cubic millimeters
Time Frame
baseline, 24, 48 and 168 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virgilio Lima Gomez, MD, MSc
Organizational Affiliation
Hospital Juarez de Mexico
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dulce M Razo Blanco Hernandez, MD
Organizational Affiliation
Hospital Juarez de Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Asbun Bojalil, MD, PhD
Organizational Affiliation
Hospital Juarez de Mexico
Official's Role
Study Director
Facility Information:
Facility Name
Virgilio Lima Gomez
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico

12. IPD Sharing Statement

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Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

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