- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00907114
Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy
Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Distrito Federal
-
Mexico, Distrito Federal, Mexico, 07760
- Virgilio Lima Gomez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ketorolac tromethamine
ocular topic ketorolac used 4 times a day during a week after panphotocoagulation
|
Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation
Other Names:
|
Placebo Comparator: Polivynilic alcohol
ocular lubricant drops 4 times a day during one week after panphotocoagulation
|
Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
center subfield mean thickness using Stratus OCT measured in microns
Time Frame: baseline, 24, 48 and 168 hours after treatment
|
baseline, 24, 48 and 168 hours after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
center point thickness using Stratus OCT, measured in microns
Time Frame: baseline, 24, 48 and 168 hours after treatment
|
baseline, 24, 48 and 168 hours after treatment
|
macular volume using Stratus OCT, measured in cubic millimeters
Time Frame: baseline, 24, 48 and 168 hours after treatment
|
baseline, 24, 48 and 168 hours after treatment
|
Collaborators and Investigators
Sponsor
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
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- 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
- Ketorolac Tromethamine
Other Study ID Numbers
- HJM 1667/09.03.24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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