Nepafenac Once Daily for Macular Edema - Study 1

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery

Conditions
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Non-Proliferative Diabetic Retinopathy, Cataract

Intervention / Treatment
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* Drug: Nepafenac Ophthalmic Suspension, 0.3%
* Other: Nepafenac vehicle
* Drug: Prednisolone acetate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nepafenac<br>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. | Drug: Nepafenac Ophthalmic Suspension, 0.3%<br>* Test intervention<br>* Other names: Nepafenac;Drug: Prednisolone acetate<br>* 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<br>* Other names: Prednisolone acetate ophthalmic suspension;|
| Placebo Comparator: Vehicle<br>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. | Other: Nepafenac vehicle<br>* Inactive ingredients used as placebo comparator<br>Drug: Prednisolone acetate<br>* 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<br>* Other names: Prednisolone acetate ophthalmic suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative 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. | Baseline to Day 14, and maintained through Day 90 | 
| Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0) | 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. | Day 0 to Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Diabetes Type I, Diabetes Type II, non-proliferative diabetic retinopathy, macular edema