epafenac Once Daily for Macular Edema - Study 2

Conditions: Cataract surgery in diabetic patients
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2013-001874-12-HU

Lead Sponsor: Alcon Research, Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 590

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 177
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 413

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;
- Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Proportion of subjects with best-corrected visual acuity (BCVA) improvement of = 15 letters from preoperative baseline to Day 14 and maintained through Day 90;Timepoint(s) of evaluation of this end point: Baseline, Day 14, Day 30, Day 60 and Day 90

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Proportion of subjects who develop macular edema (defined as = 30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery<br>- Proportion of subjects with BCVA improvement of = 15 letters from preoperative baseline to Day 90<br>- Proportion of subjects with BCVA improvement of = 15 letters from preoperative baseline to Day 60;Timepoint(s) of evaluation of this end point: As for primary endpoint