Nepafenac Once Daily for Macular Edema - Study 1
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ClinicalTrials.gov Identifier: NCT01853072 |
Recruitment Status :
Completed
First Posted : May 14, 2013
Results First Posted : August 3, 2016
Last Update Posted : August 3, 2016
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Condition or disease | Intervention/treatment | Phase |
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Non-Proliferative Diabetic Retinopathy Cataract | Drug: Nepafenac Ophthalmic Suspension, 0.3% Other: Nepafenac vehicle Drug: Prednisolone acetate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 881 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | June 2013 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
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Experimental: Nepafenac
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.
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Drug: Nepafenac Ophthalmic Suspension, 0.3%
Test intervention
Other Name: Nepafenac Drug: Prednisolone acetate 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
Other Names:
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Placebo Comparator: 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.
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Other: Nepafenac vehicle
Inactive ingredients used as placebo comparator Drug: Prednisolone acetate 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
Other Names:
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- Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90 [ Time Frame: 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.
- Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0) [ Time Frame: 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 BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90 [ Time Frame: Baseline to Day 90 ]
- Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60 [ Time Frame: 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] [ Time Frame: 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 [ Time Frame: Day 7 up to any visit through Day 90 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853072
Study Director: | Clinical Project Lead GCRA, Pharma | Alcon Research |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT01853072 |
Other Study ID Numbers: |
C-12-067 |
First Posted: | May 14, 2013 Key Record Dates |
Results First Posted: | August 3, 2016 |
Last Update Posted: | August 3, 2016 |
Last Verified: | June 2016 |
Diabetes Type I Diabetes Type II non-proliferative diabetic retinopathy macular edema Cataract |
Cataract Retinal Diseases Diabetic Retinopathy Lens Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate |
Prednisolone acetate Nepafenac Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |