Trial | NCT00440609  Report issue

Title

Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema
A Phase I/II Study Comparing the Treatment of Clinically Significant Diabetic Macular Edema (CSDME) With 0.5mg Ranibizumab, 1.0mg Ranibizumab and 2.0mg Ranibizumab

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and 2.0mg Ranibizumab.
Study Started
Mar 31
2007
Primary Completion
Nov 30
2012
Study Completion
Dec 31
2012
Last Update
Aug 02
2013
Estimate

Drug ranibizumab

0.5mg or 1.0mg intravitreal injection given monthly for 3 months then every other month if needed, for the first year.Patients may be treated monthly as needed. Patients in Cohort 1(the first 30 patients)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 24. Patients in Cohort 2(the remaining 20)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 12.Patients may receive 2.0mg ranibizumab for a period limited to 24 months following administration of the first 2.0mg dose. Patients completing 36 months will be eligible to be followed for an additional 24 months. Starting at Month 36, patients will be able to receive monthly, the assigned dose that they received/or could have received(if re-treatment criteria was met)at Month 35. 2/1/12 - the 2.0mg dose has been discontinued, all subjects will transition to the 0.5mg dose.

0.5mg transitioning to 2.0mg Active Comparator

Ranibizumab-intravitreal injection

1.0 mg transitioning to 2.0mg Active Comparator

Ranibizumab-intravitreal injection

Criteria 

Inclusion Criteria:

Type I or Type II diabetic subjects
Vision between 20/20 and 20/400
Presence of Clinically Significant Diabetic Macular Edema

Exclusion Criteria:

Presence of any condition that would prevent clear visualization of the back of the eye
Uncontrolled glaucoma
Complications of glaucoma
Inflammation inside the eye
Certain prior eye surgeries, other than cataract surgery
Other eye diseases that may compromise the vision in the study eye
Certain prior eye treatments
Pregnancy
Uncontrolled health conditions
History of heart attack
History of stroke
Current participation in another investigational trial
No Results Posted