This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.
This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Retina Vitreous Associates of Florida
Clearwater, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.
Time frame: Baseline through 24 months
Mean Number of Injections.
The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.
Time frame: 24 months
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).
Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.
Time frame: 24 months
Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.
The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.
Time frame: 24 months
Percentage of Patients Anatomically "Dry."
Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded.
Time frame: 24 Months
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