A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients - Macular Edema Incidence/Severity Reduction with NEVANAC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 260

Inclusion Criteria

1) Patients must be 18 years of age and older, of any race and either sex, 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 Type 2 diabetes 3) NPDR (mild, moderate or severe) in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale 4) Patients must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB) 5) Central subfield macular thickness ≤ 320 μm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center 6) Absence of CME or cystoid abnormalities in the study eye as detected by SD-OCT and confirmed by the reading center 7) Absence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator Current or previous ocular disease in the study eye that in the opinion of the investigator may confound assessment of the macula, the retina, or central vision, other that diabetic retinopathy 3) Focal photocoagulation for the treatment of diabetic macular edema in the study eye within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment for retinal tear or lattice degeneration is permitted) 4) Prior panretinal photocoagulation in the study eye 5) Planned multiple procedures for study eye during the cataract/IOL implantation surgery (e.g., trabeculectomy, corneal transplant) 6) Patients who have received corneal transplants in the study eye 7) Patients whose baseline cumulative corneal fluorescein staining score (i.e., sum of scores for all 5 corneal regions) for the study eye is graded as ≥5, or whose baseline corneal fluorescein staining score in any single region for the study eye is graded as ≥3 8) History of iris atrophy or chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, uveitis, iridocyclitis) in the study eye 9) Patients with a visually nonfunctional fellow eye, defined as a best-corrected visual acuity of ≤35 ETDRS letters or worse (Snellen equivalent 20/200), except when the acuity decrease is caused by a cataract. 10) Patients who are immunocompromised (e.g., patients receiving chemotherapy irradiation therapy, patients with AIDS, leukemia, or cachexia) or patients receiving dialysis 11) Patients, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs including those with current or history of keratoconjunctivitis sicca (dry eye syndrome), neurotrophic keratopathy, lid or orbit abnormalities and collagen vascular disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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