Phase 3
Completed N=615
Nepafenac Once Daily for Macular Edema - Study 1
Source: ClinicalTrials.gov NCT01853072 ↗Enrolled (actual)
615
Serious AEs
2.4%
Results posted
Aug 2016
Primary outcomePrimary: Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90 — 61.7; 43.0 Percentage of participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90 |
61.7; 43.0 | <0.001 sig |
| PRIMARY Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0) |
2.3; 17.3 | <0.001 sig |
| SECONDARY Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90 |
77.2; 67.7 | — |
| SECONDARY Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60 |
76.2; 64.7 | — |
| SECONDARY Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit] |
15.4; 27.3 | — |
| SECONDARY Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit |
9.1; 15.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01853072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.