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

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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
Enrollment 72
Recruitment Details 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 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.
Arm/Group Title IVMac q6 Arm IVMac q4 Arm
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 23 49
Completed 21 43
Not Completed 2 6
Reason Not Completed
Death             0             2
Withdrawal by Subject             2             1
Lost to Follow-up             0             3
Arm/Group Title IVMac q6 Arm IVMac q4 Arm Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 21 43 64
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 43 participants 64 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  66.7%
41
  95.3%
55
  85.9%
>=65 years
7
  33.3%
2
   4.7%
9
  14.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 43 participants 64 participants
63  (10) 62  (30) 62.5  (20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 43 participants 64 participants
Female
9
  42.9%
21
  48.8%
30
  46.9%
Male
12
  57.1%
22
  51.2%
34
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 43 participants 64 participants
21 43 64
1.Primary Outcome
Title Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline.
Hide Description The primary efficacy outcome measure is the proportion of subjects who gain two or more lines in BCVA score in the Study Eye compared with baseline at 24 weeks. The BCVA is to be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Proportion of subjects who gain two or more lines BCVA was calculated.
Arm/Group Title IVMac q6 Arm IVMac q4 Arm
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 43
Measure Type: Number
Unit of Measure: participants
3 18
2.Secondary Outcome
Title Mean Change From Baseline at Week 24 in Central Foveal Thickness
Hide Description Optical Coherence Tomography (OCT) will be used to assess the central foveal thickness of each patient. The mean change from baseline to week 24 will be calculated for each patient.
Time Frame 24 Weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24.
Hide Description

There is a possibility that some subjects may not respond to the study treatment to which they have been assigned. Macular laser treatment is considered an alternative treatment for retinal edema. A lower proportion of subjects requiring macular laser treatment would indicate a superior treatment regimen.

This will be assessed at week 12, and again at week 24.

Time Frame 24 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IVMac q6 Arm IVMac q4 Arm
Hide Arm/Group Description 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. 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.
All-Cause Mortality
IVMac q6 Arm IVMac q4 Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IVMac q6 Arm IVMac q4 Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/23 (13.04%)      12/49 (24.49%)    
Blood and lymphatic system disorders     
Septicemia  [1]  0/23 (0.00%)  0 1/49 (2.04%)  1
Cardiac disorders     
Congestive Heart Failure  [1]  0/23 (0.00%)  0 1/49 (2.04%)  1
Uncontrolled High Blood Pressure  [1]  0/23 (0.00%)  0 1/49 (2.04%)  1
Endocrine disorders     
Diabetic Ketoacidosis  [1]  0/23 (0.00%)  0 1/49 (2.04%)  1
Eye disorders     
Neovascularization of the Iris   0/23 (0.00%)  0 1/49 (2.04%)  1
Ischemic Neuropathy left eye  [1]  1/23 (4.35%)  1 1/49 (2.04%)  1
Gastrointestinal disorders     
Diarrhea  [2]  1/23 (4.35%)  1 0/49 (0.00%)  0
Severe Retrosternal Chest Pain  [1]  0/23 (0.00%)  0 1/49 (2.04%)  1
Hepatobiliary disorders     
Pancreatitis   1/23 (4.35%)  1 0/49 (0.00%)  0
Investigations     
Unknown Death  [3]  0/23 (0.00%)  0 1/49 (2.04%)  1
Unknown Death  [4]  0/23 (0.00%)  0 1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders     
Left Hip Fracture * [1]  0/23 (0.00%)  0 1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  [1]  0/23 (0.00%)  0 1/49 (2.04%)  1
Skin and subcutaneous tissue disorders     
Pneumonia  [1]  0/23 (0.00%)  0 1/49 (2.04%)  1
Left Foot Abcess  [1]  1/23 (4.35%)  1 0/49 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
not related to study drug
[2]
Non study drug related
[3]
cause of death was unknown upon completion of the trial
[4]
cause of death was unknown at the completion of the trial
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IVMac q6 Arm IVMac q4 Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/43 (0.00%)    
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
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