CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Macugen® pegaptanib sodiumdrug
Likely dose
Macugen® pegaptanib sodium 0.3 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01486238
NCT01486238Phase 4Completed
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Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study

Valley Retina Institute·interventional·Posted Dec 6, 2011·Updated Jul 16, 2013

In Brief

A Phase 4 clinical trial evaluating Macugen® pegaptanib sodium for Diabetic Macular Edema. Completed, enrolled 72 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2011
Enrollment StartApr 1, 2009
Primary CompletionJul 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.6 years ago

Interventions

Macugen® pegaptanib sodiumdrug

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.