Macugen Observational Study

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00735943

First received: August 14, 2008

Last updated: August 26, 2011

Last verified: August 2011

History of Changes

Results First Received: July 21, 2011

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Prospective
Conditions:	Vascular Endothelial Growth Factor Macular Degeneration
Intervention:	Other: No intervention

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
Pegaptanib	Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.

Participant Flow: Overall Study

	Pegaptanib
STARTED	22
COMPLETED	20
NOT COMPLETED	2
Lost to Follow-up	1
Adverse Event	1

Baseline Characteristics

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Reporting Groups

	Description
Pegaptanib	Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.

Baseline Measures

	Pegaptanib
Number of Participants [units: participants]	22
Age [units: years] Mean ± Standard Deviation	70.4 ± 10.9
Gender [units: participants]
Female	8
Male	14

Outcome Measures

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1. Primary:

Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA) [ Time Frame: Baseline through 12 months or last follow-up visit before study termination ]

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2. Primary:

Average Number of Injections to Achieve Stabilization of VA [ Time Frame: 12 months or last follow-up visit before study termination ]

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3. Primary:

Median Number of Injections to Achieve Stabilization of VA [ Time Frame: 12 months or last follow-up visit before study termination ]

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4. Secondary:

Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy [ Time Frame: 12 months or last follow-up visit before study termination ]

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5. Secondary:

Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters [ Time Frame: 12 months or last follow-up visit before study termination ]

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6. Secondary:

Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters [ Time Frame: 12 months or last follow-up visit before study termination ]

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7. Secondary:

Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA [ Time Frame: 12 months or last follow-up visit before study termination ]

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8. Secondary:

Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions [ Time Frame: 12 months or last follow-up visit before study termination ]

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9. Secondary:

Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions [ Time Frame: 12 months or last follow-up visit before study termination ]

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10. Secondary:

Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA [ Time Frame: 12 months or last follow-up visit before study termination ]

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11. Secondary:

Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen [ Time Frame: 12 months or last follow-up visit before study termination ]

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12. Secondary:

Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy [ Time Frame: 12 months or last follow-up visit before study termination ]

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13. Secondary:

Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy [ Time Frame: 12 months or last follow-up visit before study termination ]

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14. Secondary:

Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive [ Time Frame: 12 months or last follow-up visit before study termination ]

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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
Outcome measures were not designated as primary or secondary measures as this study was an observational non-interventional study.

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:	Pfizer
ClinicalTrials.gov Identifier:	NCT00735943 History of Changes
Other Study ID Numbers:	A5751031
Study First Received:	August 14, 2008
Results First Received:	July 21, 2011
Last Updated:	August 26, 2011
Health Authority:	India: Institutional Review Board

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