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Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

This study has been completed.
Information provided by (Responsible Party):
Virgilio Lima Gomez, Hospital Juarez de Mexico Identifier:
First received: May 11, 2009
Last updated: March 18, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Diabetic Retinopathy
Macular Edema
Drug: Ketorolac
Drug: Nepafenac
Drug: Polietilenglicol 400, propilenglicol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema

Resource links provided by NLM:

Further study details as provided by Hospital Juarez de Mexico:

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 [ Time Frame: one week after treatment ]

Secondary Outcome Measures:
  • center point thickness using stratus OCT measured in microns [ Time Frame: before treatment, at 24, 48 and 168 hours after treatment ]
  • macular volume using stratus OCT measured in cubic millimeters [ Time Frame: before treatment, 24, 48 and 168 hours after treatment ]
  • visual capacity under subjective refractive correction measured in decimal equivalent [ Time Frame: before treatment, at 24, 48, 168 hours after treatment ]

Enrollment: 84
Study Start Date: April 2008
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketorolac
ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation
Drug: Ketorolac
ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week
Other Name: Godek
Active Comparator: Nepafenac
ocular topic nepafenac 3 times a day during one week after selective photocoagulation
Drug: Nepafenac
topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week
Other Name: Nevanac
Placebo Comparator: Polietilenglicol 400, propilenglicol
ocular lubricant drops 3 times a day for a week after selective photocoagulation
Drug: Polietilenglicol 400, propilenglicol

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

Other Name: Systane

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.

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00900887

Virgilio Lima Gomez
Mexico, Distrito Federal, Mexico, 07760
Sponsors and Collaborators
Hospital Juarez de Mexico
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

Responsible Party: Virgilio Lima Gomez, PhD, Hospital Juarez de Mexico Identifier: NCT00900887     History of Changes
Other Study ID Numbers: HJM 1470/08.03.18
Study First Received: May 11, 2009
Last Updated: March 18, 2015

Keywords provided by Hospital Juarez de Mexico:
diabetic retinopathy
clinically significant macular edema
selective photocoagulation
topic ketorolac
topic nepafenac

Additional relevant MeSH terms:
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ketorolac Tromethamine
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017