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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00782717
• Collaborator: (none)
• Enrollment: 263
• Arms: 2
• Duration (Months): 19.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema	Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC); Other: Nepafenac ophthalmic suspension vehicle; Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 263 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Nepafenac 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.; Other Names: NEVANAC ; Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED); One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.; Other Names: OMNIPRED
Placebo Comparator: 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.	Other: Nepafenac ophthalmic suspension vehicle; 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery; Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED); One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.; Other Names: OMNIPRED

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00782717
• Other Study ID Numbers: C-07-43
• First Posted: Oct 31, 2008
• Last Update Posted: Oct 26, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Alcon Research: diabetic retinopathy; cystoid macular edema
• Additional relevant MeSH terms: Cataract; Macular Edema; Retinal Diseases; Diabetic Retinopathy; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Nepafenac; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

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 Detail	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.

Arm/Group Title	NEVANAC	Nepafenac Vehicle
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	133	130
COMPLETED	118	102
NOT COMPLETED	15	28

Baseline Characteristics

Arm/Group Title	NEVANAC	Nepafenac Vehicle	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	125	126	251
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	46 36.8%	54 42.9%	100 39.8%
>=65 years	79 63.2%	72 57.1%	151 60.2%
Sex: Female, Male (Count of Participants)
Female	83 66.4%	75 59.5%	158 62.9%
Male	42 33.6%	51 40.5%	93 37.1%

Outcome Measures

1. Primary Outcome

Title	Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	NEVANAC	Nepafenac Vehicle
Arm/Group Description	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.	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.
Measure Participants	125	126
Number [Percentage of patients]	3	17

2. Secondary Outcome

Title	Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	NEVANAC	Nepafenac Vehicle
Arm/Group Description	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.	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.
Measure Participants	124	122
Number [Percentage of patients]	6	12

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 04 NOV 2008 to 15 JUL 2010.
Adverse Event Reporting Description	The safety population included all patients who received exposure or potential exposure to the study drug.
Arm/Group Title	NEVANAC		Nepafenac Vehicle
Arm/Group Description	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.		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.
All Cause Mortality
	NEVANAC		Nepafenac Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	NEVANAC		Nepafenac Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/126 (3.2%)		9/127 (7.1%)
Cardiac disorders
Coronary artery disease	1/126 (0.8%)	1	0/127 (0%)	0
Cardiac failure congestive	0/126 (0%)	0	1/127 (0.8%)	1
Coronary artery occlusion	0/126 (0%)	0	1/127 (0.8%)	1
Gastrointestinal disorders
Pancreatitis	0/126 (0%)	0	1/127 (0.8%)	1
General disorders
Device failure	1/126 (0.8%)	1	0/127 (0%)	0
Chest discomfort	0/126 (0%)	0	1/127 (0.8%)	1
Chest pain	0/126 (0%)	0	1/127 (0.8%)	1
Infections and infestations
Osteomyelitis	1/126 (0.8%)	1	0/127 (0%)	0
Labyrnthitis	0/126 (0%)	0	1/127 (0.8%)	1
Injury, poisoning and procedural complications
Injury	0/126 (0%)	0	1/127 (0.8%)	1
Metabolism and nutrition disorders
Hypoglycaemia	1/126 (0.8%)	1	0/127 (0%)	0
Nervous system disorders
Syncope	0/126 (0%)	0	1/127 (0.8%)	1
Renal and urinary disorders
Renal failure acute	0/126 (0%)	0	1/127 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/126 (0%)	0	1/127 (0.8%)	1
Vascular disorders
Hypertension	0/126 (0%)	0	1/127 (0.8%)	1
Other (Not Including Serious) Adverse Events
	NEVANAC		Nepafenac Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/126 (7.1%)		19/127 (15%)
Eye disorders
Eye Pain	1/126 (0.8%)	1	3/127 (2.4%)	3
Eye inflammation	0/126 (0%)	0	3/127 (2.4%)	3
Infections and infestations
Urinary tract infection	0/126 (0%)	0	3/127 (2.4%)	3
Injury, poisoning and procedural complications
Injury	5/126 (4%)	5	5/127 (3.9%)	5
Metabolism and nutrition disorders
Diabetes mellitus	0/126 (0%)	0	3/127 (2.4%)	3
Vascular disorders
Hypertension	3/126 (2.4%)	3	5/127 (3.9%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right to review study related information prior to presentation or publication