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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philip J. ferrone, M.D., Long Island Vitreoretinal Consultants
ClinicalTrials.gov Identifier:
NCT00440609
First received: February 23, 2007
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Clinically Significant Diabetic Macular Edema
Drug: ranibizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Long Island Vitreoretinal Consultants:

Primary Outcome Measures:
  • To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema [ Time Frame: month 12 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm. [ Time Frame: month 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm [ Time Frame: month 12, 24, 36,48 and 60 ] [ Designated as safety issue: No ]
  • Changes observed on the fluorescein angiogram in each arm [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
  • Mean number of ranibizumab injections required in each arm [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
  • The need for "rescue therapy" with laser in each arm [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Month 60 ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: March 2007
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440609

Locations
United States, New York
Long Island Vitreoretinal Consultants
Great Neck, New York, United States, 11021
Long Island Vitreoretinal Consultants
Hauppauge, New York, United States, 11749
Sponsors and Collaborators
Philip J. ferrone, M.D.
Investigators
Principal Investigator: Philip J. Ferrone, MD Long Island Vitreoretinal Consultants
  More Information

No publications provided

Responsible Party: Philip J. ferrone, M.D., Prinicpal Investigator, Long Island Vitreoretinal Consultants
ClinicalTrials.gov Identifier: NCT00440609     History of Changes
Other Study ID Numbers: FVF3802s
Study First Received: February 23, 2007
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014