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The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEVANAC | Experimental | One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. |
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| Nepafenac Vehicle | Placebo Comparator | One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac ophthalmic suspension, 0.1% (NEVANAC) | Drug | 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery | Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT). | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). | BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study. | From Day 7 to Day 90 (or Early Exit) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22927737 | Result | Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, Sall K, Walters T, Sager D. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol. 2012;6:1259-69. doi: 10.2147/OPTH.S31902. Epub 2012 Aug 3. | |
| 27388251 | Derived | Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh RP. Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy. Br J Ophthalmol. 2017 Apr;101(4):423-427. doi: 10.1136/bjophthalmol-2016-308617. Epub 2016 Jul 7. |
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Of the 263 patients enrolled, 12 exited prior to surgery. Baseline characteristics are presented for the ITT population, i.e., patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit.
Patients were recruited from 41 investigative centers from November 2008 to July 2010. 263 patients diagnosed with diabetic retinopathy and requiring cataract extraction with intraocular lens implantation were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | NEVANAC | One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. |
| FG001 | Nepafenac Vehicle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Nepafenac ophthalmic suspension vehicle | Other | 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery |
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| Prednisolone acetate ophthalmic suspension (OMNIPRED) | Drug | One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery. |
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One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NEVANAC | One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. |
| BG001 | Nepafenac Vehicle | One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery | Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT). | All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT). | Posted | Number | Percentage of patients | 3 Months |
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| Secondary | Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). | BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study. | All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT). | Posted | Number | Percentage of patients | From Day 7 to Day 90 (or Early Exit) |
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Adverse events were collected for the duration of the study: 04 NOV 2008 to 15 JUL 2010.
The safety population included all patients who received exposure or potential exposure to the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NEVANAC | One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. | 4 | 126 | 9 | 126 | ||
| EG001 | Nepafenac Vehicle | One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. | 9 | 127 | 19 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Device failure | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Labyrnthitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Eye inflammation | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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Sponsor reserves the right to review study related information prior to presentation or publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 888.451.3937 and 817.568.6725 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| >=65 years |
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| Male |
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