Study Comparing Two Doses of Ranibizumab in the Treatment of Clinically Significant Diabetic Macular Edema - Full Text View

Sponsored by:	Long Island Vitreoretinal Consultants
Information provided by:	Long Island Vitreoretinal Consultants
ClinicalTrials.gov Identifier:	NCT00440609

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 to those receiving 1.0mg Ranibizumab.

Condition	Intervention	Phase
Clinically Significant Diabetic Macular Edema	Drug: ranibizumab	Phase I Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Study Comparing the Treatment of Clinically Significant Diabetic Macular Edema (CSDME) With 0.5gm Ranibizumab to 1.0mg Ranibizumab

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 and 24 in each arm. [ Time Frame: month 12 and 24 ] [ Designated as safety issue: No ]
Mean change in central retinal thickness on OCT from baseline to month 12 and 24 in each arm [ Time Frame: month 12 and 24 ] [ Designated as safety issue: No ]
Changes observed on the fluorescein angiogram in each arm [ Time Frame: month 24 ] [ Designated as safety issue: No ]
Mean number of ranibizumab injections required in each arm [ Time Frame: month 24 ] [ Designated as safety issue: No ]
The need for "rescue therapy" with laser in each arm [ Time Frame: month 24 ] [ Designated as safety issue: No ]
Evaluate the efficacy and safety of ranibizumab inthe fellow eye in the sub-group of patients who require treatment for clinically significant diabetic macular edema in the fellow eye [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
0.5 mg ranibizumab: Active Comparator	Drug: ranibizumab 0.5 mg or 1.0 mg intravitreal injection given monthly for 3 months followed by every other month treatment, on an as needed basis
1.0 mg ranibizumab: Active Comparator intravitreal injection	Drug: ranibizumab 0.5 mg or 1.0 mg intravitreal injection given monthly for 3 months followed by every other month treatment, on an as needed basis

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

Contacts

Contact: Marianne Schlameuss, RN

516-466-0390 ext 222

mschlameuss@longislandretina.com

Locations

United States, New York
Long Island Vitreoretinal Consultants	Recruiting
Great Neck, New York, United States, 11021
Contact: Marianne Schlameuss, RN 516-466-0390 ext 222 mschlameuss@longislandretina.com
Long Island Vitreoretinal Consultants	Recruiting
Hauppauge, New York, United States, 11749
Contact: Ann Marie Lavorna, RN 631-234-5666 alavorna@longislandretina.com

Sponsors and Collaborators

Long Island Vitreoretinal Consultants

Investigators

Principal Investigator:

Philip J. Ferrone, MD

Long Island Vitreoretinal Consultants

More Information

Responsible Party:	Long Island Vitreoretinal Consultants ( Philip J. Ferrone, M.D. )
Study ID Numbers:	FVF3802s
Study First Received:	February 23, 2007
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00440609
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Macular Edema
Eye Diseases
Retinal Degeneration

Macular Degeneration
Edema
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 14, 2009