Nepafenac Once Daily for Macular Edema - Study 1

Phase 3

Completed

• Conditions: Non-Proliferative Diabetic Retinopathy; Cataract
• Interventions: Other: Nepafenac vehicle; Drug: Nepafenac Ophthalmic Suspension, 0.3%; Drug: Prednisolone acetate

• Registration Number: NCT01853072
• Lead Sponsor: Alcon Research

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 subjects following cataract surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-14
• Study Start: 2013-06
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-05-13
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-23
• Last Update Submitted: 2016-06-23
• Results First Posted: 2016-08-03
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 881

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Nepafenac 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.
Nepafenac	Nepafenac Ophthalmic Suspension, 0.3%	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.
Vehicle	Prednisolone acetate	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.
Nepafenac	Prednisolone acetate	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)	Day 0 to Day 90	Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.
Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90	Baseline to Day 14, and maintained through Day 90	BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90	Baseline to Day 90
Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60	Baseline to Day 60
Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]	Day 7 up to any visit through Day 90
Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit	Day 7 up to any visit through Day 90