Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	Macular Degeneration
Intervention:	Drug: pegaptanib sodium (Macugen)

Participant Flow

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 Sodium	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.

Participant Flow: Overall Study

	Pegaptanib Sodium
STARTED	81^[1]
COMPLETED	49
NOT COMPLETED	32
Adverse Event	5
Lack of Efficacy	17
Withdrawal by Subject	5
unknown	5

[1]	subjects received treatment

Baseline Characteristics

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Reporting Groups

	Description
Pegaptanib Sodium	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.

Baseline Measures

	Pegaptanib Sodium
Number of Participants [units: participants]	81
Age [units: years] Mean ± Standard Deviation	76.3 ± 6.7
Gender [units: participants]
Female	47
Male	34

Outcome Measures

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1. Primary:

Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) [ Baseline, 54 Weeks ]

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Measure Type	Primary
Measure Title	Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
Measure Description	Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.
Time Frame	Baseline, 54 Weeks
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.
The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.

Reporting Groups

	Description
Pegaptanib Sodium	All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.

Measured Values

	Pegaptanib Sodium
Number of Participants Analyzed [units: participants]	80
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) [units: participants]
Responders	40
Non-Responders	7
Censored (subjects with missing data)	33

Statistical Analysis 1 for Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)

Groups ^[1]	Pegaptanib Sodium
percent responders ^[2]	85
95% Confidence Interval	( 76 to 95 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant estimation information:
	Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.

2. Secondary:

Change From Baseline in Visual Acuity [ Baseline, 6 weeks, 12 weeks, 54 weeks ]

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3. Secondary:

Number of Subjects Gaining Vision [ 54 weeks or at early termination ]

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4. Secondary:

Number of Subjects Maintaining Vision [ 54 weeks or at early termination ]

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5. Secondary:

Number of Subjects With Severe Visual Loss [ 54 weeks or at early termination ]

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6. Secondary:

Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) [ 54 weeks ]

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7. Secondary:

Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). [ Baseline, 54 weeks or at early 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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 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.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5751016
Study First Received:	May 8, 2006
Results First Received:	August 25, 2009
Last Updated:	November 10, 2009
ClinicalTrials.gov Identifier:	NCT00324116 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency