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

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Ranibizumab

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	March 2007
Estimated Study Completion Date:	November 2014
Estimated 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.

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

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:	April 12, 2012
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 June 18, 2013