Intravitreal injections of pegaptanib every 4 weeks will be efficacious in treating Diabetic Macular Edema (DME), as compared to injections every 6 weeks.
This is a 24 week clinical study which will be double-masked. Subjects will be 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. Fellow eyes of patients with two eligible eyes will be monitored and treated with standard clinical care. If sufficient fellow eyes are treated, this will provide an internal control group for direct comparison of the Macugen® treated study eyes versus the fellow eyes. Both study eyes and fellow eyes will be assessed in the same fashion at every time point during this study. Each site is to have at least one Unmasked investigator to perform the study injections and one Masked investigator to perform study evaluations and assess adverse events. Roles cannot be reversed after study treatment for a given subject has begun. 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. Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6 week intervals beginning on Day 0 and ending at Week 18. Each Macugen® injection will be administered as described in the package insert.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Patients assigned to either arm (IVMac q4 and IVMac q6) will receive 0.3 milligrams (mg) of pegaptanib sodium delivered by intravitreal injection administered. 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. Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6 week intervals beginning on Day 0 and ending at Week 18. Each Macugen® injection will be administered as described in the package insert.
Valley Retina Institute,PA
McAllen, Texas, United States
Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline.
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
Mean Change From Baseline at Week 24 in Central Foveal Thickness
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
Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24.
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
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