Clinical trial NCT00440609: Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Clinically Significant Diabetic Macular Edema
Lead sponsor: Long Island Vitreoretinal Consultants
Sponsor class: OTHER
First posted: 2007-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema
timeFrame: month 12
measure: To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab
timeFrame: month 12
Secondary outcomes:
measure: Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm.
timeFrame: month 12, 24, 36, 48 and 60
measure: Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm
timeFrame: month 12, 24, 36,48 and 60
measure: Changes observed on the fluorescein angiogram in each arm
timeFrame: Month 60
measure: Mean number of ranibizumab injections required in each arm
timeFrame: Month 60
measure: The need for "rescue therapy" with laser in each arm
timeFrame: Month 60
measure: 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
timeFrame: Month 60
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: Hauppauge
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
Study officials:
affiliation: Long Island Vitreoretinal Consultants
name: Philip J. Ferrone, MD
role: PRINCIPAL_INVESTIGATOR
References: