Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy
This study is currently recruiting participants.
Verified March 2010 by Hospital Juarez de Mexico
Sponsor:
Hospital Juarez de Mexico
Information provided by (Responsible Party):
Virgilio Lima Gomez, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier:
NCT00907114
First received: May 19, 2009
Last updated: December 4, 2012
Last verified: March 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Proliferative Diabetic Retinopathy Macular Edema |
Drug: Ketorolac tromethamine Drug: Alcohol polivinilico |
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 and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
U.S. FDA Resources
Further study details as provided by Hospital Juarez de Mexico:
Primary Outcome Measures:
- center subfield mean thickness using Stratus OCT measured in microns [ Time Frame: baseline, 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- center point thickness using Stratus OCT, measured in microns [ Time Frame: baseline, 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]
- macular volume using Stratus OCT, measured in cubic millimeters [ Time Frame: baseline, 24, 48 and 168 hours after treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ketorolac tromethamine
ocular topic ketorolac used 4 times a day during a week after panphotocoagulation
|
Drug: Ketorolac tromethamine
Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation
Other Name: Godek
|
|
Placebo Comparator: Placebo
ocular lubricant drops 4 times a day during one week after panphotocoagulation
|
Drug: Alcohol polivinilico
Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation
Other Name: Acuafil
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907114
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: | NCT00907114 History of Changes |
| Other Study ID Numbers: | HJM 1667/09.03.24 |
| Study First Received: | May 19, 2009 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Mexico: Federal Commission for Sanitary Risks Protection United States: Federal Government |
Keywords provided by Hospital Juarez de Mexico:
|
proliferative diabetic retinopathy macular edema panphotocoagulation |
topic ketorolac 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 Ketorolac Tromethamine |
Ketorolac Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013