A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life. (MACURELI)

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00549055

First received: October 23, 2007

Last updated: February 15, 2011

Last verified: February 2011

History of Changes

Results First Received: October 1, 2010

Study Type:	Observational
Study Design:	Observational Model: Cohort
Condition:	Exudative Age-related Macular Degeneration
Intervention:	Drug: Macugen

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Macugen	Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.

Participant Flow: Overall Study

	Macugen
STARTED	38
COMPLETED	3
NOT COMPLETED	35
Adverse Event	4
Lack of efficacy	18
Stabilization	5
Progression to fibrosis	2
Decrease of size	1
Active choroidal neovascula increased	1
Vitreous hemorrhage	1
Growth choroidal neovascularisation	1
Choroidal neovascularization	1
Very low visual acuity (VA)	1

Baseline Characteristics

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Reporting Groups

	Description
Macugen	Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.

Baseline Measures

	Macugen
Number of Participants [units: participants]	38
Age, Customized [units: Participants]
< 65 years	3
65 to 74 years	8
75 to 84 years	22
>= 85 years	5
Gender [units: Participants]
Female	14
Male	24

Outcome Measures

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1. Primary:

Change From Baseline to Final Visit in Visual Acuity (VA) Score [ Time Frame: Baseline, Month 24 or Early Termination ]

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2. Secondary:

Number of Participants With Change in VA: Improvement [ Time Frame: Months 3, 6, 9 and 12 ]

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3. Secondary:

Number of Participants With Change in VA: Stabilization [ Time Frame: Months 3, 6, 9 and 12 ]

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4. Secondary:

Number of Participants With Change in VA: Worsening [ Time Frame: Months 3, 6, 9 and 12 ]

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5. Secondary:

Duration of Treatment [ Time Frame: Baseline up to 28.4 months ]

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Measure Type	Secondary
Measure Title	Duration of Treatment
Measure Description	Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).
Time Frame	Baseline up to 28.4 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Macugen	Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.

Measured Values

	Macugen
Number of Participants Analyzed [units: participants]	30
Duration of Treatment [units: Months] Mean ± Standard Deviation	4.66 ± 5.26

No statistical analysis provided for Duration of Treatment

6. Secondary:

Frequency of Macugen Administration [ Time Frame: Baseline up to 28.4 months ]

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7. Secondary:

Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments [ Time Frame: Months 3, 6, 9 and 12 ]

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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: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00549055 History of Changes
Other Study ID Numbers:	A5751026
Study First Received:	October 23, 2007
Results First Received:	October 1, 2010
Last Updated:	February 15, 2011
Health Authority:	Belgium: Institutional Review Board

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