None listed
Conditions
Interventions
Nepafenac Ophthalmic Suspension,
0.3%
Sponsors
ALCON RESEARCH LTD.,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be 18 years of age and older who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens into the lens capsule 2. History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale and confirmed by the reading center. 3. Subjects must have preoperative screening Early Treatment of Diabetic Retinopathy Study (ETDRS) bestcorrected visual acuity (BCVA) of 73 letters or worse in the study eye to participate in the study 4. Subject’s study eye must, in the opinion of the Investigator, have expectation of improvement in BCVA after surgery 5. Subjects must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Exclusion criteria
Exclusion criteria: 1. Pre-existing macular edema in the study eye as determined by SD-OCT and confirmed by the reading center 2. Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by SD-OCT or fundus exam per reading center or Investigator 3. History in the study eye of: Retinal detachment, Ischemic maculopathy, CRVO, BRVO, CRAO, BRAO, wet AMD, Chronic or recurrent inflammatory eye disease 4. Prior procedures in the study eye: as it is detailed in page N° 4 5. Planned procedures:as it is detailed in page N° 4 6. Medications:as it is detailed in page N° 5 7. Known or suspected allergy or hypersensitivity to NSAIDs, corticosteroids, or to any component of the investigational product. Subjects with known medical history of intolerance to fluorescein are also excluded. 8. Subjects whose baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) is graded as ≥ 5, or whose baseline corneal fluorescein staining score in any single region for the study eye is graded as ≥ 3 9. Subjects requiring dialysis whose treatment may impact compliance with the visit schedule And others criteria as it is detailed on page N° 6 and 7
Countries
Australia, Austria, Colombia, France, Germany, Hungary, Israel, Italy, Mexico, Philippines, Singapore, Spain
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed