A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00605280

First received: January 18, 2008

Last updated: July 5, 2012

Last verified: July 2012

History of Changes

Results First Received: November 18, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Macular Edema Associated With Diabetes Mellitus
Interventions:	Drug: Standard of Care 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
Original protocol included 0.3, 0.03, and 0.003 milligram (mg) pegaptanib sodium and sham treatment groups; the 0.03 and 0.003 mg doses were removed, affected participants given option of receiving 0.3 mg injections of pegaptanib sodium or study withdraw. Later, participants who hadn't completed Year 2 were eligible to enroll in Year 3 extension.

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
0.3 mg Pegaptanib Sodium	Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
0.03 mg Pegaptanib Sodium	Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks for 2 years or withdrawing from the study.
0.003 mg Pegaptanib Sodium	Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from the study.
Sham	Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.

Participant Flow for 3 periods

Period 1: Year 1

	0.3 mg Pegaptanib Sodium	0.03 mg Pegaptanib Sodium	0.003 mg Pegaptanib Sodium	Sham
STARTED	145	22	7	143
Received 0.3 mg Treatment	144	13	3	0
COMPLETED	126	11	6	124
NOT COMPLETED	19	11	1	19
Protocol Violation	0	0	0	1
Adverse Event	3	1	1	5
Physician Decision	7	4	0	6
Withdrawal by Subject	2	4	0	4
Unspecified	2	1	0	1
Lost to Follow-up or Patient non-comply	5	1	0	2

Period 2: Year 2

	0.3 mg Pegaptanib Sodium	0.03 mg Pegaptanib Sodium	0.003 mg Pegaptanib Sodium	Sham
STARTED	126	11	6	124
Received 0.3 mg Treatment	126	3	2	0
COMPLETED	102	5	0	102
NOT COMPLETED	24	6	6	22
Adverse Event	4	0	2	4
Physician Decision	11	6	4	11
Withdrawal by Subject	4	0	0	4
Unspecified	1	0	0	1
Lost to Follow-up or Patient non-comply	4	0	0	2

Period 3: Year 3 Extension

	0.3 mg Pegaptanib Sodium	Sham
STARTED	46	54
Received 0.3 mg Treatment	46	54
COMPLETED	38	45
NOT COMPLETED	8	9
Adverse Event	2	2
Physician Decision	0	2
Withdrawal by Subject	2	5
Unspecified	2	0
Lost to Follow-up or Patient non-comply	2	0

Baseline Characteristics

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Reporting Groups

	Description
0.3 mg Pegaptanib Sodium	Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
Sham	Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
0.03 mg Pegaptanib Sodium	Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
0.003 mg Pegaptanib Sodium	Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
Total	Total of all reporting groups

Baseline Measures

	0.3 mg Pegaptanib Sodium	Sham	0.03 mg Pegaptanib Sodium	0.003 mg Pegaptanib Sodium	Total
Number of Participants [units: participants]	145	143	22	7	317
Age [units: Years] Mean ± Standard Deviation	62.5 ± 9.2	62.4 ± 10.3	64.7 ± 8.6	57.3 ± 10.1	62.5 ± 9.7
Gender [units: Participants]
Female	59	65	11	4	139
Male	86	78	11	3	178

Outcome Measures

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1. Primary:

Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year [ Time Frame: Baseline, Year 1 ]

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2. Secondary:

Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years [ Time Frame: Baseline, Year 2 ]

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3. Secondary:

Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year [ Time Frame: Baseline, Year 1 ]

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4. Secondary:

Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years [ Time Frame: Baseline, Year 2 ]

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5. Secondary:

Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year [ Time Frame: Baseline, Year 1 ]

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6. Secondary:

Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year [ Time Frame: Baseline, Year 1 ]

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7. Secondary:

Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years [ Time Frame: Baseline, Year 2 ]

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8. Secondary:

Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years [ Time Frame: Baseline, Year 2 ]

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9. Secondary:

Change From Baseline in Mean VA Score at 1 Year [ Time Frame: Baseline, Year 1 ]

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10. Secondary:

Change From Baseline in Mean VA Score at 2 Years [ Time Frame: Baseline, Year 2 ]

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11. Secondary:

Number of Participants Requiring Focal or Grid Laser Treatment During Year 1 [ Time Frame: 1 year ]

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12. Secondary:

Number of Participants Requiring Focal or Grid Laser Treatment During Year 2 [ Time Frame: 2 years ]

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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:	Pfizer
ClinicalTrials.gov Identifier:	NCT00605280 History of Changes
Obsolete Identifiers:	NCT00148811
Other Study ID Numbers:	A5751013, EOP1013H
Study First Received:	January 18, 2008
Results First Received:	November 18, 2010
Last Updated:	July 5, 2012
Health Authority:	United States: Food and Drug Administration

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