Clinical trial NCT01853072: Nepafenac Once Daily for Macular Edema - Study 1
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Proliferative Diabetic Retinopathy
Cataract
Keywords: Diabetes Type I
Diabetes Type II
non-proliferative diabetic retinopathy
macular edema
Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-05-14
Enrollment: 881
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;
* 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.

Primary outcomes:
measure: Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
timeFrame: Baseline to Day 14, and maintained through Day 90
measure: Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
timeFrame: Day 0 to Day 90
Secondary outcomes:
measure: Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
timeFrame: Baseline to Day 90
measure: Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
timeFrame: Baseline to Day 60
measure: Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]
timeFrame: Day 7 up to any visit through Day 90
measure: Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
timeFrame: Day 7 up to any visit through Day 90
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Project Lead GCRA, Pharma
role: STUDY_DIRECTOR
References: