Trial Outcomes & Findings for Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study (NCT NCT01486238)
NCT ID: NCT01486238
Last Updated: 2013-07-16
Results Overview
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.
COMPLETED
PHASE4
72 participants
24 weeks
2013-07-16
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
49
|
|
Overall Study
COMPLETED
|
21
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study
Baseline characteristics by cohort
| Measure |
IVMac q6 Arm
n=21 Participants
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
n=43 Participants
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
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age Continuous
|
63 years
STANDARD_DEVIATION 10 • n=99 Participants
|
62 years
STANDARD_DEVIATION 30 • n=107 Participants
|
62.5 years
STANDARD_DEVIATION 20 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
43 participants
n=107 Participants
|
64 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Proportion of subjects who gain two or more lines BCVA was calculated.
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.
Outcome measures
| Measure |
IVMac q6 Arm
n=21 Participants
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
n=43 Participants
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.
|
|---|---|---|
|
Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline.
|
3 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 24 WeeksOptical 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksThere 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.
Outcome measures
Outcome data not reported
Adverse Events
IVMac q6 Arm
IVMac q4 Arm
Serious adverse events
| Measure |
IVMac q6 Arm
n=21 participants at risk；n=23 participants at risk
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
n=43 participants at risk；n=49 participants at risk
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.
|
|---|---|---|
|
Hepatobiliary disorders
Pancreatitis
|
4.3%
1/23 • Number of events 1
|
0.00%
0/49
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Number of events 1
|
0.00%
0/49
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pneumonia
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Left Foot Abcess
|
4.3%
1/23 • Number of events 1
|
0.00%
0/49
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
|
Eye disorders
Neovascularization of the Iris
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Severe Retrosternal Chest Pain
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
|
Blood and lymphatic system disorders
Septicemia
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Uncontrolled High Blood Pressure
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
|
Eye disorders
Ischemic Neuropathy left eye
|
4.3%
1/23 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
|
Investigations
Unknown Death
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Left Hip Fracture
|
0.00%
0/23
|
2.0%
1/49 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place