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

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 Overview

• Status: Completed
• Conditions: Clinically Significant Diabetic Macular Edema
• Intervention / Treatment: Drug: ranibizumab

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Vitreoretinal Consultants
    • Hauppauge, New York, United States, 11749
      • Long Island Vitreoretinal Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.5mg transitioning to 2.0mg; Ranibizumab-intravitreal injection	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.
Active Comparator: 1.0 mg transitioning to 2.0mg; Ranibizumab-intravitreal injection	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema	month 12
To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab	month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Philip J. ferrone, M.D.
• Investigators: Principal Investigator: Philip J. Ferrone, MD, Long Island Vitreoretinal Consultants

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 23, 2007
• First Submitted That Met QC Criteria: February 23, 2007
• First Posted (Estimate): February 27, 2007

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: FVF3802s