Trial Outcomes & Findings for Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery (NCT NCT00494494)

Results Overview

The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

82 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2011-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Treatment These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.	Nepafenac 1 drop per study eye three times per day for 30 days plus standard care
Overall Study STARTED	40	39
Overall Study COMPLETED	40	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Treatment n=40 Participants These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.	Nepafenac n=39 Participants 1 drop per study eye three times per day for 30 days plus standard care	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Age Continuous	70.33 years STANDARD_DEVIATION 8.04 • n=5 Participants	73.95 years STANDARD_DEVIATION 8.99 • n=7 Participants	72.14 years STANDARD_DEVIATION 8.52 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	39 participants n=7 Participants	79 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: Three subjects in the treatment group and two subjects in the control group had unreliable preoperative OCT scans because of dense posterior subcapsular cataracts. These subjects were excluded from the analysis.

The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)

Outcome measures

Outcome measures
Measure	Standard Treatment n=40 Participants These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.	Nepafenac n=39 Participants 1 drop per study eye three times per day for 30 days plus standard care
Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)	2.78 microns Interval -10.12 to 15.68	5.6 microns Interval -8.2 to 19.4

PRIMARY outcome

Timeframe: baseline

Population: The analysis was per protocol. At baseline, everybody was given a Best Corrected Visual Acuity Assessment (BCVA).

Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.

Outcome measures

Outcome measures
Measure	Standard Treatment n=40 Participants These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.	Nepafenac n=39 Participants 1 drop per study eye three times per day for 30 days plus standard care
Pre-operative Best Corrected Visual Acuity (BCVA)	38.48 letters Standard Deviation 9.83	40.49 letters Standard Deviation 9.56

PRIMARY outcome

Timeframe: baseline and 8 weeks

difference in mean pre-post changes by the two treatment groups

Outcome measures

Outcome measures
Measure	Standard Treatment n=40 Participants These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.	Nepafenac n=39 Participants 1 drop per study eye three times per day for 30 days plus standard care
Foveal Thickness	-2.0 microns Interval -25.4 to 21.4	4.7 microns Interval -14.9 to 24.3

PRIMARY outcome

Timeframe: baseline and 8 weeks

Outcome measures

Outcome measures
Measure	Standard Treatment n=40 Participants These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.	Nepafenac n=39 Participants 1 drop per study eye three times per day for 30 days plus standard care
Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)	0.05 microns Interval -0.46 to 0.56	0.10 microns Interval -0.11 to 0.31

PRIMARY outcome

Timeframe: baseline and 8 weeks

The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.

Outcome measures

Outcome measures
Measure	Standard Treatment n=40 Participants These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.	Nepafenac n=39 Participants 1 drop per study eye three times per day for 30 days plus standard care
Post-operative Best Corrected Visual Acuity (BCVA)	54.46 letters Interval 39.0 to 67.0	55.49 letters Interval 44.0 to 65.0

Adverse Events

Standard Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nepafenac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kennth L. Cohen, MD

University of North Carolina at Chapel Hill

Phone: 919 843-0292

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place