A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01100307
First received: April 7, 2010
Last updated: August 16, 2013
Last verified: May 2013
Results First Received: May 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Macular Edema
Diabetic Mellitus
Retinal Disease
Interventions: Drug: pegaptanib sodium
Other: sham injection

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pegaptanib Sodium Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
Sham in Double Masked, Then Pegaptanib Sodium in Open Phase Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.

Participant Flow for 2 periods

Period 1:   Double Masked Phase (Up to Week 24)
    Pegaptanib Sodium     Sham in Double Masked, Then Pegaptanib Sodium in Open Phase  
STARTED     123     120  
COMPLETED     117     116  
NOT COMPLETED     6     4  
Lack of Efficacy                 1                 1  
Withdrawal by Subject                 0                 1  
Adverse Event                 5                 2  

Period 2:   Open Phase (Week 24 up to Week 54)
    Pegaptanib Sodium     Sham in Double Masked, Then Pegaptanib Sodium in Open Phase  
STARTED     116 [1]   112 [2]
COMPLETED     110     99  
NOT COMPLETED     6     13  
Lack of Efficacy                 1                 2  
Withdrawal by Subject                 2                 3  
Adverse Event                 3                 8  
[1] One participant discontinued from the study due to adverse event before study drug administration.
[2] Four participants did not enter to the open phase after completing the double masked phase.



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Pegaptanib Sodium Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
Sham in Double Masked, Then Pegaptanib Sodium in Open Phase Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
Total Total of all reporting groups

Baseline Measures
    Pegaptanib Sodium     Sham in Double Masked, Then Pegaptanib Sodium in Open Phase     Total  
Number of Participants  
[units: participants]
  123     120     243  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     52     49     101  
>=65 years     71     71     142  
Gender  
[units: participants]
     
Female     58     55     113  
Male     65     65     130  



  Outcome Measures
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1.  Primary:   Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Change From Baseline in Visual Acuity (VA): Double Masked Phase   [ Time Frame: Baseline, Weeks 6, 12, 18, and 24 ]

3.  Secondary:   Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase   [ Time Frame: Up to 24 weeks ]

4.  Secondary:   Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase   [ Time Frame: Baseline and Week 54 ]

5.  Secondary:   Change From Baseline in Visual Acuity (VA): Open Phase   [ Time Frame: Baseline, Weeks 30, 36, 42, 48 and 54 ]

6.  Secondary:   Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase   [ Time Frame: Weeks 24 to 54 ]

7.  Other Pre-specified:   Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase   [ Time Frame: Baseline, Weeks 6, 12, 18, and 24 ]

8.  Other Pre-specified:   Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase   [ Time Frame: Baseline, Weeks 6, 12, 18, and 24 ]

9.  Other Pre-specified:   Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase   [ Time Frame: Baseline, Weeks 6, 12, 18, and 24 ]

10.  Other Pre-specified:   Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase   [ Time Frame: Baseline and Week 24 ]

11.  Other Pre-specified:   Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase   [ Time Frame: Baseline and Week 24 ]

12.  Other Pre-specified:   Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase   [ Time Frame: Baseline and Week 24 ]

13.  Other Pre-specified:   Mean Visual Acuity Over Time at Each Time Point: Open Phase   [ Time Frame: Baseline, Weeks 30, 36, 42, 48, and 54 ]

14.  Other Pre-specified:   Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase   [ Time Frame: Baseline, Weeks 30, 36, 42, 48, and 54 ]

15.  Other Pre-specified:   Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase   [ Time Frame: Baseline, Weeks 30, 36, 42, 48, and 54 ]

16.  Other Pre-specified:   Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase   [ Time Frame: Baseline and Week 54 ]

17.  Other Pre-specified:   Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase   [ Time Frame: Baseline and Week 54 ]

18.  Other Pre-specified:   Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase   [ Time Frame: Baseline and Week 54 ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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
During the study, an issue was reported concerning proper maintenance of treatment masking. Due to this masking process issue, the study results cannot be interpreted as that arising from a well-controlled double-masked trial.  


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: NCT01100307     History of Changes
Other Study ID Numbers: A5751034
Study First Received: April 7, 2010
Results First Received: May 15, 2013
Last Updated: August 16, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare