Phase
Condition
Eye Disorders/infections
Macular Edema
Diabetic Retinopathy
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Planned cataract extraction by phacoemulsification with implantation of a posteriorchamber intraocular lens;
History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
Best corrected visual acuity (BCVA) of 73 letters or worse in the study eye withexpectation of improvement after surgery;
Understand and sign an informed consent document;
Other protocol-defined inclusion criteria may apply.
Exclusion
Exclusion Criteria:
Pre-existing macular edema in the study eye;
History in the study eye of retinal detachment, wet age-related macular degeneration,chronic or recurrent inflammatory eye disease, or prior procedures;
Planned cataract surgery in the fellow eye after randomization and prior to the Day 90postoperative study visit or through study exit;
Planned multiple procedures for the study eye during the cataract/intraocular lensimplantation surgery;
Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol.
Participation in any other clinical study within 30 days of the screening visit;
Females of childbearing potential who are breast feeding, have a positive urinepregnancy test at screening, are not willing to undergo a urine pregnancy test uponentering or exiting the study, intend to become pregnant during the study, or do notagree to use adequate birth control methods for the duration of the study;
Other protocol-defined exclusion criteria may apply.
Study Design
Connect with a study center
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas 76134
United StatesSite Not Available
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