NCT01486238

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Valley Retina Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intravitreal injections of pegaptanib every 4 weeks will be efficacious in treating Diabetic Macular Edema (DME), as compared to injections every 6 weeks.

Detailed description

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Macugen® pegaptanib sodium	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.

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-07-01
• Completion: 2011-10-01
• First posted: 2011-12-06
• Last updated: 2013-07-16
• Results posted: 2013-07-16

Locations

1 site across 1 country: United States