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

This study has been completed.

Study NCT00782717 Information provided by Alcon Research

First Received on October 29, 2008. Last Updated on November 28, 2011 History of Changes

Results First Received: August 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Macular Edema
Interventions:	Drug: nepafenac Drug: Nepafenac vehicle

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited from 35 investigative centers from November 2008 to July 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
263 patients diagnosed with diabetic retinopathy and required cataract extraction with intraocular lens (IOL) implantation were randomized to Nevanac or vehicle.

Reporting Groups

	Description
Nevanac, 0.1%	NEVANAC; one drop in eye three times daily
Nepafenac Vehicle	Nepafenac vehicle; one drop in eye three times daily.

Participant Flow: Overall Study

	Nevanac, 0.1%	Nepafenac Vehicle
STARTED	133	130
COMPLETED	118	102
NOT COMPLETED	15	28

Baseline Characteristics

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Reporting Groups

	Description
Nevanac, 0.1%	NEVANAC; one drop in eye three times daily
Nepafenac Vehicle	Nepafenac vehicle; one drop in eye three times daily.

Baseline Measures

	Nevanac, 0.1%	Nepafenac Vehicle	Total
Number of Participants [units: participants]	125	126	251
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	46	54	100
>=65 years	79	72	151
Gender [units: participants]
Female	83	75	158
Male	42	51	93

Outcome Measures

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1. Primary:

The Percentage of Diabetic Retinopathy Patients Who Develop Macular Edema (ME) Within 90 Days Following Cataract Surgery [ Time Frame: 3 Months ]

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2. Secondary:

The Percentage of Patients Who Had a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). [ Time Frame: From day 7 to day 90 (or Early Exit) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor reserves the right to review study related information prior to presentation or publication

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937 and 817.568.6725
e-mail: medinfo@alconlabs.com

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00782717 History of Changes
Other Study ID Numbers:	C-07-43
Study First Received:	October 29, 2008
Results First Received:	August 17, 2011
Last Updated:	November 28, 2011
Health Authority:	United States: Food and Drug Administration