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

Philip J. ferrone, M.D.1 site in 1 country50 target enrollmentMarch 2007

ConditionsClinically Significant Diabetic Macular Edema

Interventionsranibizumab

Drugsranibizumab

Overview

Phase: Phase 1
Intervention: ranibizumab
Conditions: Clinically Significant Diabetic Macular Edema
Sponsor: Philip J. ferrone, M.D.
Enrollment: 50
Locations: 1
Primary Endpoint: To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

December 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Philip J. ferrone, M.D.

Responsible Party

Sponsor Investigator

Principal Investigator

Philip J. ferrone, M.D.

Prinicpal Investigator

Long Island Vitreoretinal Consultants

Eligibility 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

Arms & Interventions

0.5mg transitioning to 2.0mg

Ranibizumab-intravitreal injection

Intervention: ranibizumab

1.0 mg transitioning to 2.0mg

Ranibizumab-intravitreal injection

Intervention: ranibizumab

Outcomes

Primary Outcomes

To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema

Time Frame: month 12

To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab

Time Frame: month 12

Secondary Outcomes

Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm.(month 12, 24, 36, 48 and 60)
Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm(month 12, 24, 36,48 and 60)
Changes observed on the fluorescein angiogram in each arm(Month 60)
Mean number of ranibizumab injections required in each arm(Month 60)
The need for "rescue therapy" with laser in each arm(Month 60)
Evaluate the efficacy and safety of ranibizumab in the fellow eye in the sub-group of patients who require treatment for clinically significant diabetic macular edema in the fellow eye(Month 60)