Nepafenac Once Daily for Macular Edema - Study 2

NCT ID: NCT01872611

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 819 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-05-31

Brief Summary

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 participants following cataract surgery.

Conditions

Non-Proliferative Diabetic Retinopathy; Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nepafenac

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.

Group Type: EXPERIMENTAL

Nepafenac Ophthalmic Suspension, 0.3%

Intervention Type: DRUG

Prednisolone acetate

Intervention Type: DRUG

1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

Vehicle

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.

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: OTHER

Inactive ingredients used as placebo comparator

Prednisolone acetate

Intervention Type: DRUG

1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

Interventions

Nepafenac Ophthalmic Suspension, 0.3%

Intervention Type: DRUG

Vehicle

Inactive ingredients used as placebo comparator

Intervention Type: OTHER

Prednisolone acetate

1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks

Intervention Type: DRUG

Other Intervention Names

Test intervention; Nepafenac Vehicle; Omnipred™; Prednisolone acetate ophthalmic suspension

Eligibility Criteria

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;

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 prior to the Day 90 postoperative study visit or through study exit;
• Planned multiple procedures for the study eye during the cataract/intraocular lens;
• 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Project Lead GCRA, Pharma

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

2013-001874-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C-12-071

Identifier Type: -

Identifier Source: org_study_id