Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900887
• Other study ID #: HJM 1470/08.03.18
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2009
• Last updated: March 18, 2015
• Start date: April 2008
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Hospital Juarez de Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks ProtectionUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Diseases

Intervention

Drug:
• Ketorolac
ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week
• Nepafenac
topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week
• 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

Locations

Country	Name	City	State
Mexico	Virgilio Lima Gomez	Mexico	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Juarez de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	center point thickness using stratus OCT measured in microns		before treatment, at 24, 48 and 168 hours after treatment	No
Secondary	macular volume using stratus OCT measured in cubic millimeters		before treatment, 24, 48 and 168 hours after treatment	No
Secondary	visual capacity under subjective refractive correction measured in decimal equivalent		before treatment, at 24, 48, 168 hours after treatment	No