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Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Primary Purpose

Diabetic Retinopathy, Macular Edema

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Ketorolac
Nepafenac
Polietilenglicol 400, propilenglicol
Sponsored by
Hospital Juarez de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, clinically significant macular edema, selective photocoagulation, topic ketorolac, topic nepafenac, efficacy, treatment

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 2 diabetes
  • regardless of diabetes duration and retinopathy severity level
  • one or both eyes with focal clinically significant macular edema
  • treated with selective or focal photocoagulation
  • visual capacity under subjective refraction before treatment
  • adequate quality 6mm fast macular map on the day of photocoagulation
  • signed of inform consent

Exclusion Criteria:

  • ocular surgery in the last 4 months
  • previous selective photocoagulation
  • topic or systemic antiinflammatory therapy in the last week
  • allergic to antiinflammatory non-steroids therapy
  • lent contact used in tha last 2 days before photocoagulation
  • history of ocular trauma, ocular infection or lacrimal dysfunction in the last 3 months
  • history of uveitis or ocular inflammation in the last 12 months
  • any ocular external disease, infection or inflammatory process during evaluation
  • corneal abnormalities that could modify visual capacity per se
  • actual corneal disease
  • pregnancy
  • myopia over -6.00 diopters
  • any retinal disease different from diabetic retinopathy
  • adverse event of the drug
  • desert to pharmacology therapy after the second visit
  • no assistance after the second visit
  • inadequate quality 6mm fast macular map after the second visit

Sites / Locations

  • Virgilio Lima Gomez

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ketorolac

Nepafenac

Polietilenglicol 400, propilenglicol

Arm Description

ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation

ocular topic nepafenac 3 times a day during one week after selective photocoagulation

ocular lubricant drops 3 times a day for a week after selective photocoagulation

Outcomes

Primary Outcome Measures

ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation

Secondary Outcome Measures

center point thickness using stratus OCT measured in microns
macular volume using stratus OCT measured in cubic millimeters
visual capacity under subjective refractive correction measured in decimal equivalent

Full Information

First Posted
May 11, 2009
Last Updated
March 18, 2015
Sponsor
Hospital Juarez de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT00900887
Brief Title
Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema
Official Title
Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (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 of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.
Detailed Description
Selective photocoagulation is the standard treatment for clinically significant macular edema. This treatment decreased the incidence of moderate visual loss in the long term. Nonetheless, in the first six weeks after treatment it is induced, probably because an exacerbation of macular edema secondary to treatment. An inflammatory response has been reported after selective photocoagulation. Therefore, antiinflammatory therapy like ketorolac or nepafenac could be useful to manage center point thickness secondary to selective photocoagulation in diabetics with macular edema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Macular Edema
Keywords
diabetic retinopathy, clinically significant macular edema, selective photocoagulation, topic ketorolac, topic nepafenac, efficacy, treatment

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation
Arm Title
Nepafenac
Arm Type
Active Comparator
Arm Description
ocular topic nepafenac 3 times a day during one week after selective photocoagulation
Arm Title
Polietilenglicol 400, propilenglicol
Arm Type
Placebo Comparator
Arm Description
ocular lubricant drops 3 times a day for a week after selective photocoagulation
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Godek
Intervention Description
ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week
Intervention Type
Drug
Intervention Name(s)
Nepafenac
Other Intervention Name(s)
Nevanac
Intervention Description
topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week
Intervention Type
Drug
Intervention Name(s)
Polietilenglicol 400, propilenglicol
Other Intervention Name(s)
Systane
Intervention Description
ocular presentation Polietilenglicol 400 (4 mg), propilenglicol (3 mg), HP guar (1.9 mg)/1 ml dosage: one drop (0.2 mg polietinglicol 400, 0.15 mg propilenglicol, 0.095 mg HP guar) 3 times a day during one week
Primary Outcome Measure Information:
Title
ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation
Time Frame
one week after treatment
Secondary Outcome Measure Information:
Title
center point thickness using stratus OCT measured in microns
Time Frame
before treatment, at 24, 48 and 168 hours after treatment
Title
macular volume using stratus OCT measured in cubic millimeters
Time Frame
before treatment, 24, 48 and 168 hours after treatment
Title
visual capacity under subjective refractive correction measured in decimal equivalent
Time Frame
before treatment, at 24, 48, 168 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 2 diabetes regardless of diabetes duration and retinopathy severity level one or both eyes with focal clinically significant macular edema treated with selective or focal photocoagulation visual capacity under subjective refraction before treatment adequate quality 6mm fast macular map on the day of photocoagulation signed of inform consent Exclusion Criteria: ocular surgery in the last 4 months previous selective photocoagulation topic or systemic antiinflammatory therapy in the last week allergic to antiinflammatory non-steroids therapy lent contact used in tha last 2 days before photocoagulation history of ocular trauma, ocular infection or lacrimal dysfunction in the last 3 months history of uveitis or ocular inflammation in the last 12 months any ocular external disease, infection or inflammatory process during evaluation corneal abnormalities that could modify visual capacity per se actual corneal disease pregnancy myopia over -6.00 diopters any retinal disease different from diabetic retinopathy adverse event of the drug desert to pharmacology therapy after the second visit no assistance after the second visit inadequate quality 6mm fast macular map after the second visit
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 Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

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