A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients

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
2)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)Patients with history of iris atrophy or current or history of chronic or recurrent ocular infections or inflammation in the study eye
9)Patients with a visually non-functional fellow eye based upon the assessment by the investigator.
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 or steroids including those with current or history of keratoconjunctivitis sicca (dry eye syndrome), neurotrophic keratopathy, corneal or scleral thinning and collagen vascular disease, contact lens users, and those with known bleeding tendencies
12)Patients with current or history of asthma, urticaria, or acute rhinitis in whom attacks are precipitated by acetylsalicylic acid or other NSAIDs
13)Use of medications known to affect the macula, including hydroxychloroquinine (Plaquenil) and phenothiozines (e.g., thioridazine [Mellaril], chloropromazine [Thorazine]) or supplemental niacin =3 grams/day
14)Use of daily doses of systemic steroids and NSAIDS within 7 days prior to surgery (through study exit). Daily doses of aspirin, up to 325 mg, will be permitted.
15)Use of daily doses of topical ocular steroids and NSAIDs in the nonstudy eye through study exit (Note: All topical ocular steroids and NSAIDs must be discontinued 1 day prior to surgery)
16)Use of topical ocular NSAIDS and steroids, in the study eye, within 7 days prior to surgery
17)Treatment with intraocular or periocular steroids in the study eye within 4 months prior to surgery
18)Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication including Tobradex®
19)Use of a topical ophthalmic prostaglandin (e.g., TRAVATAN, XALATAN) within 4 days of surgery through study exit
20)The Alcon Medical Monitor may declare any patient ineligible for a valid medical reason.
21)Participation in any other clinical study within 30 days of the Baseline examination
22)Each patient will have only one eye enrolled in the study
23)Females of childbearing potential (those who are not surgically sterilized or post-menopausal) may not participate in the study if any of the following conditions exist:
they are breast-feeding; they have a positive urine pregnancy test at scre

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate superiority of NEVANAC® (nepafenac ophthalmic suspension) 0.1% relative to nepafenac vehicle based on the percentage of diabetic retinopathy patients who develop macular edema (defined as =30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery.;Secondary Objective: N/A;Primary end point(s): percentage of patients who develop macular edema (defined as =30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery

Secondary Outcome Measures

Name	Time	Method

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