Trial Outcomes & Findings for A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients (NCT NCT00782717)

Last Updated: 2012-10-26

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

263 participants

Primary outcome timeframe

3 Months

Results posted on

2012-10-26

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	133	130
Overall Study COMPLETED	118	102
Overall Study NOT COMPLETED	15	28

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	2	5
Overall Study Patient decision unrelated to AE	6	3
Overall Study Noncompliance	2	1
Overall Study Treatment failure	3	14
Overall Study Enrollment close prior to surgery	1	0
Overall Study Did not meet entrance criteria	1	3
Overall Study Exited in error	0	2

Baseline Characteristics

A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NEVANAC n=125 Participants 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.	Nepafenac Vehicle n=126 Participants 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.	Total n=251 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	46 Participants n=5 Participants	54 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	79 Participants n=5 Participants	72 Participants n=7 Participants	151 Participants n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	75 Participants n=7 Participants	158 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	51 Participants n=7 Participants	93 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	NEVANAC n=125 Participants 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.	Nepafenac Vehicle n=126 Participants 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.
Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery	3 Percentage of patients	17 Percentage of patients

SECONDARY outcome

Timeframe: From Day 7 to Day 90 (or Early Exit)

BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.

Outcome measures

Outcome measures
Measure	NEVANAC n=124 Participants 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.	Nepafenac Vehicle n=122 Participants 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.
Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).	6 Percentage of patients	12 Percentage of patients

Adverse Events

NEVANAC

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Nepafenac Vehicle

Serious events: 9 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	NEVANAC n=126 participants at risk 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.	Nepafenac Vehicle n=127 participants at risk 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.
Eye disorders Eye Pain	0.79% 1/126 • Number of events 1 • 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.	2.4% 3/127 • Number of events 3 • 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.
Eye disorders Eye inflammation	0.00% 0/126 • 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.	2.4% 3/127 • Number of events 3 • 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.
Infections and infestations Urinary tract infection	0.00% 0/126 • 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.	2.4% 3/127 • Number of events 3 • 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.
Injury, poisoning and procedural complications Injury	4.0% 5/126 • Number of events 5 • 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.	3.9% 5/127 • Number of events 5 • 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.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/126 • 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.	2.4% 3/127 • Number of events 3 • 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.
Vascular disorders Hypertension	2.4% 3/126 • Number of events 3 • 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.	3.9% 5/127 • Number of events 5 • 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.

Additional Information

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937 and 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right to review study related information prior to presentation or publication
Publication restrictions are in place

Restriction type: OTHER

Measure	NEVANAC n=126 participants at risk 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.	Nepafenac Vehicle n=127 participants at risk 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.
Cardiac disorders Coronary artery disease	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/127 • 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.
General disorders Device failure	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/127 • 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.
Infections and infestations Osteomyelitis	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/127 • 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.
Metabolism and nutrition disorders Hypoglycaemia	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/127 • 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.
Cardiac disorders Cardiac failure congestive	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
Cardiac disorders Coronary artery occlusion	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
Gastrointestinal disorders Pancreatitis	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
General disorders Chest discomfort	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
General disorders Chest pain	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
Infections and infestations Labyrnthitis	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
Injury, poisoning and procedural complications Injury	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
Nervous system disorders Syncope	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
Renal and urinary disorders Renal failure acute	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.
Vascular disorders Hypertension	0.00% 0/126 • 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.	0.79% 1/127 • Number of events 1 • 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.