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Trial record 15 of 20 for:    "Papilledema"

Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study (PRESERVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01486238
Recruitment Status : Completed
First Posted : December 6, 2011
Results First Posted : July 16, 2013
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
Valley Retina Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Intervention: Drug: Macugen® pegaptanib sodium

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients will be recruited from a single medical clinic (Valley Retina Institute), and randomly assigned 2:1 to Macugen® every 4 weeks (IVMac q4 arm) or Macugen® every 6 weeks (IVMac q6 arm). If both eyes are eligible, then one eye will be randomized into the trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled patients must have DME in one or both eyes. In patients with both eyes that meet criteria, only 1 eye will be considered eligible. All fellow eyes in these patients will be treated according to standard clinical guidelines.

Reporting Groups
  Description
IVMac q6 Arm Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
IVMac q4 Arm Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.

Participant Flow:   Overall Study
    IVMac q6 Arm   IVMac q4 Arm
STARTED   23   49 
COMPLETED   21   43 
NOT COMPLETED   2   6 
Death                0                2 
Withdrawal by Subject                2                1 
Lost to Follow-up                0                3 



  Baseline Characteristics

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.

In the IVMac q6 Arm, 23 subjects started the study. Two (2) subjects withdrew early. For this reason data from the 21 remaining subjects was used.

In the IVMac q4 Arm, 49 subjects started the study. 6 subjects were lost in this arm - 2 died, 1 withdrew, & 3 were lost to follow-up. For this reason data from the 43 remaining subjects was used.


Reporting Groups
  Description
IVMac q6 Arm Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
IVMac q4 Arm Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
Total Total of all reporting groups

Baseline Measures
   IVMac q6 Arm   IVMac q4 Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   43   64 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   14   41   55 
>=65 years   7   2   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (10)   62  (30)   62.5  (20) 
Gender 
[Units: Participants]
     
Female   9   21   30 
Male   12   22   34 
Region of Enrollment 
[Units: Participants]
     
United States   21   43   64 


  Outcome Measures

1.  Primary:   Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline.   [ Time Frame: 24 weeks ]

2.  Secondary:   Mean Change From Baseline at Week 24 in Central Foveal Thickness   [ Time Frame: 24 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24.   [ Time Frame: 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Victor Gonzalez, MD
Organization: Valley Retina Institute, PA
phone: 956-631-8875
e-mail: research@vritx.com



Responsible Party: Valley Retina Institute
ClinicalTrials.gov Identifier: NCT01486238     History of Changes
Other Study ID Numbers: PRESERVE
First Submitted: December 2, 2011
First Posted: December 6, 2011
Results First Submitted: April 2, 2013
Results First Posted: July 16, 2013
Last Update Posted: July 16, 2013