Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema

Conditions

• Clinically Significant Diabetic Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab — DRUG
  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.

Study Details

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.

Key Dates

First listed

Feb 27, 2007

Start date

Mar 31, 2007

Status verified

Aug 2013

Primary completion

Nov 30, 2012

Completion

Dec 31, 2012

Study Design

Enrollment

50 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 0.5mg transitioning to 2.0mg
  Ranibizumab-intravitreal injection
• Active Comparator: 1.0 mg transitioning to 2.0mg
  Ranibizumab-intravitreal injection

Primary Outcome Measure

To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema [ Time Frame: month 12 ]

Locations (2)

Find similar trials in Great Neck, NY