Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema
NCT ID: NCT00440609
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2007-03-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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0.5mg transitioning to 2.0mg
Ranibizumab-intravitreal injection
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.
1.0 mg transitioning to 2.0mg
Ranibizumab-intravitreal injection
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.
Interventions
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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 Criteria
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Inclusion Criteria
* Vision between 20/20 and 20/400
* Presence of Clinically Significant Diabetic Macular Edema
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Philip J. ferrone, M.D.
OTHER
Responsible Party
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Philip J. ferrone, M.D.
Prinicpal Investigator
Principal Investigators
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Philip J. Ferrone, MD
Role: PRINCIPAL_INVESTIGATOR
Long Island Vitreoretinal Consultants
Locations
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Long Island Vitreoretinal Consultants
Great Neck, New York, United States
Long Island Vitreoretinal Consultants
Hauppauge, New York, United States
Countries
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Other Identifiers
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FVF3802s
Identifier Type: -
Identifier Source: org_study_id