Macular Edema Incidence/Severity Reduction With Nevanac
NCT ID: NCT00939276
Last Updated: 2012-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
175 participants
INTERVENTIONAL
2009-08-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NEVANAC
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Nepafenac Vehicle
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Nepafenac ophthalmic suspension vehicle
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Interventions
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Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Nepafenac ophthalmic suspension vehicle
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of Type 1 or Type 2 diabetes.
* History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.
* Able to understand and sign an informed consent approved by an IRB/IEC.
* Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery.
* Absence of clinically significant macular edema in the study eye as detected by clinical exam.
Exclusion Criteria
* Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.
* Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant).
* Corneal transplant in study eye.
* Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Locations
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Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States
Countries
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References
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Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh RP. Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy. Br J Ophthalmol. 2017 Apr;101(4):423-427. doi: 10.1136/bjophthalmol-2016-308617. Epub 2016 Jul 7.
Other Identifiers
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EudraCT Number: 2009-010536-17
Identifier Type: -
Identifier Source: secondary_id
C-09-003
Identifier Type: -
Identifier Source: org_study_id