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

Clinically Significant Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440609
• Other study ID #: FVF3802s
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 23, 2007
• Last updated: August 1, 2013
• Start date: March 2007
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Long Island Vitreoretinal Consultants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clinically Significant Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
United States	Long Island Vitreoretinal Consultants	Great Neck	New York
United States	Long Island Vitreoretinal Consultants	Hauppauge	New York

Sponsors (1)

Lead Sponsor	Collaborator
Philip J. ferrone, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema		month 12
Primary	To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab		month 12
Secondary	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
Secondary	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
Secondary	Changes observed on the fluorescein angiogram in each arm		Month 60
Secondary	Mean number of ranibizumab injections required in each arm		Month 60
Secondary	The need for "rescue therapy" with laser in each arm		Month 60
Secondary	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