A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
Conditions
Interventions
None listed
Sponsors
Alcon Laboratories
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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 nonfunctional 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 condi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Key Secondary Efficacy: Percentage of patients with a best-corrected visual acuity (BCVA) decrease of >5 ETDRS letters from the Day 7 postoperative visit Safety: • adverse events o incidence of adverse events o targeted adverse events • intraocular pressure • slit-lamp parameters o inflammatory cells o aqueous flare o corneal edema o bulbar conjunctival injection o corneal epithelium integrity [as assessed by corneal fluorescein staining] • dilated fundus parameters o retina/macula/choroid o optic nerve | — |
Countries
Netherlands
Outcome results
None listed