Nepafenac Once Daily for Macular Edema - Study 1

Alcon

Status and phase: Completed; Phase 3

Conditions: Cataract; Non-Proliferative Diabetic Retinopathy

Treatments: Other: Nepafenac vehicle; Drug: Prednisolone acetate; Drug: Nepafenac Ophthalmic Suspension, 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01853072

C-12-067

Details and patient eligibility

About

The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.

Enrollment: 881 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens;
• History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
• Best corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery;
• Understand and sign an informed consent document;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Pre-existing macular edema in the study eye;
• History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures;
• Planned cataract surgery in the fellow eye after randomization and prior to the Day 90 postoperative study visit or through study exit;
• Planned multiple procedures for the study eye during the cataract/intraocular lens implantation surgery;
• Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol.
• Participation in any other clinical study within 30 days of the screening visit;
• Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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881 participants in 2 patient groups, including a placebo group

Nepafenac

Experimental group

Description:

With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

Treatment:

Drug: Prednisolone acetate

Drug: Nepafenac Ophthalmic Suspension, 0.3%

Vehicle

Placebo Comparator group

Description:

With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

Treatment:

Drug: Prednisolone acetate

Other: Nepafenac vehicle