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Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

This study is currently recruiting participants.
Verified March 2013 by Hospital Juarez de Mexico
Sponsor:
Information provided by (Responsible Party):
Virgilio Lima Gomez, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier:
NCT00900887
First received: May 11, 2009
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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: Tromethamine ketorolac
Drug: Nepafenac
Drug: Polietilenglicol 400, propilenglicol, HP guar
 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 of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • center point thickness using stratus OCT measured in microns [ Time Frame: before treatment, at 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]
  • macular volume using stratus OCT measured in cubic millimeters [ Time Frame: before treatment, 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]
  • visual capacity under subjective refractive correction measured in decimal equivalent [ Time Frame: before treatment, at 24, 48, 168 hours after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: April 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (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: Tromethamine 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: Placebo
ocular lubricant drops 3 times a day for a week after selective photocoagulation
 Drug: Polietilenglicol 400, propilenglicol, HP guar

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900887

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: NCT00900887     History of Changes
Other Study ID Numbers: HJM 1470/08.03.18
Study First Received: May 11, 2009
Last Updated: March 26, 2013
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection
United States: Federal Government

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

ClinicalTrials.gov processed this record on May 21, 2013