Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy; Macular Edema
• Intervention / Treatment: Drug: Ketorolac; Drug: Nepafenac; Drug: Polietilenglicol 400, propilenglicol

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 07760
      • Virgilio Lima Gomez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: Systane

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 11, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (Estimate): May 13, 2009

Study Record Updates

• Last Update Posted (Estimate): March 20, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: treatment; efficacy; diabetic retinopathy; clinically significant macular edema; selective photocoagulation; topic ketorolac; topic nepafenac
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Macular Degeneration; Retinal Diseases; Diabetic Retinopathy; Macular Edema; Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Nepafenac
• Other Study ID Numbers: HJM 1470/08.03.18