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

Alcon

Status and phase: Completed; Phase 2

Conditions: Macular Edema

Treatments: Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED); Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC); Other: Nepafenac ophthalmic suspension vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782717

C-07-43

Details and patient eligibility

About

The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.

Enrollment: 263 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Central subfiled macular thickness greater than or equal to 250 microns
• CME in either eye.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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263 participants in 2 patient groups, including a placebo group

NEVANAC

Experimental group

Description:

One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.

Treatment:

Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC)

Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)

Nepafenac Vehicle

Placebo Comparator group

Description:

One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.

Treatment:

Other: Nepafenac ophthalmic suspension vehicle

Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)