Macular Edema
Conditions
Keywords
diabetic retinopathy, cystoid macular edema;
Brief summary
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.
Interventions
DRUGNepafenac ophthalmic suspension, 0.1% (NEVANAC)
1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.
1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
DRUGPrednisolone acetate ophthalmic suspension (OMNIPRED)
One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Central subfiled macular thickness greater than or equal to 250 microns * CME in either eye. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery | 3 Months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). | From Day 7 to Day 90 (or Early Exit) | BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study. |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 125 |
| 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. | 126 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 |
| Overall Study | Did not meet entrance criteria | 1 | 3 |
| Overall Study | Enrollment close prior to surgery | 1 | 0 |
| Overall Study | Exited in error | 0 | 2 |
| Overall Study | Noncompliance | 2 | 1 |
| Overall Study | Patient decision unrelated to AE | 6 | 3 |
| Overall Study | Treatment failure | 3 | 14 |
Baseline characteristics
| Characteristic | NEVANAC | Nepafenac Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 79 Participants | 72 Participants | 151 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 54 Participants | 100 Participants |
| Sex: Female, Male Female | 83 Participants | 75 Participants | 158 Participants |
| Sex: Female, Male Male | 42 Participants | 51 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 126 | 19 / 127 |
| serious Total, serious adverse events | 4 / 126 | 9 / 127 |
Outcome results
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).
Time frame: 3 Months
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NEVANAC | Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery | 3 Percentage of patients |
| Nepafenac Vehicle | Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery | 17 Percentage of patients |
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.
Time frame: From Day 7 to Day 90 (or Early Exit)
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NEVANAC | Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). | 6 Percentage of patients |
| Nepafenac Vehicle | Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). | 12 Percentage of patients |