Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

Macular Edema Clinical Trial

Official title:

Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907114
• Other study ID #: HJM 1667/09.03.24
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2009
• Last updated: March 18, 2015
• Start date: June 2009
• 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 and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.

Description:

Panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3 to 4 sessions within 2 weeks. This treatment reduces the incidence of severe visual loss in the long term. Nonetheless, it induces macular thickness that delays the conclusion of the treatment. This delay could coincide with vitreous hemorrhage which, in turn, may limit additional photocoagulation.

Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes

• proliferative diabetic retinopathy

• without macular edema

• adequate quality 6 mm fast macular map on the day of treatment

• visual capacity under subjective refraction before treatment

• signed of inform consent

Exclusion Criteria:

• ocular surgery in the last 4 months

• myopia over -6.00 diopters

• allergy to ketorolac or non-steroids antiinflammatory

• previous selective photocoagulation

• using non-steroids antiinflammatory or immunomodulators

• intraocular inflammatory

• any retinal disease different from diabetic retinopathy

• pregnancy

• actual corneal disease

• inadequate quality 6 mm fast macular map after the second visit

• inconsistency after the second visit

• adverse event of the drug

• remove of the inform consent

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
• Macular Edema
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Ketorolac tromethamine
Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation
• Polivynilic alcohol
Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation

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	center subfield mean thickness using Stratus OCT measured in microns		baseline, 24, 48 and 168 hours after treatment	No
Secondary	center point thickness using Stratus OCT, measured in microns		baseline, 24, 48 and 168 hours after treatment	No
Secondary	macular volume using Stratus OCT, measured in cubic millimeters		baseline, 24, 48 and 168 hours after treatment	No