Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab

30 eyes will be randomized in a 1:2 ratio (Group A= 10 patients; Group B= 20 patients) Group
A: ("monthly group")- Consented patient with enrolled eye will receive 12 monthly required
injections of 0.3mg ranibizumab over 1 year OR Group B: ("As needed (PRN) Group")- Consented
patient with enrolled eye will receive 6 monthly required injections of 0.3mg ranibizumab
for 6 months, followed by as needed (PRN) dosing (required ranibizumab if DME persistent on
Optical Coherence Tomography (OCT) and Early Treatment Diabetic Retina Study (ETDRS) Best
Corrected Visual Acuity (BCVA) <20/20) for 6 months.

Inclusion Criteria:

- Ability to provide written informed consent and comply with study assessments for the
full duration of the study.

- >=18 years

- Type I/II diabetes mellitus

- Central-involved DME in study eye (OCT CSF >=275um on Heidelberg Spectralis spectral
domain OCT with evidence of intraretinal or subretinal fluid or cysts)

- Definite retinal thickening due to diabetic macular edema involving the center of the
macula.

- Media clarity, pupillary dilation and individual cooperation for adequate fungus
photography and fluorescein angiography.

- Visual Acuity score in study eye <=80 and >=20 (approximate Snellen equivalent 20/25
to 20/400).

- History of at least 6 intravitreal bevacizumab injections within the past 9 months
and 2 intravitreal bevacizumab injections within the past 2 months.

- No history of an anti-VEGF treatment for DME in the past 3 weeks.

- No other DME treatment for DME, other than bevacizumab, in the study eye at any time
in the past 3 months.

- No history of major ocular surgery in the study eye within prior 3 months or
anticipated within the next six months following randomization.

Exclusion Criteria:

- Pregnancy or lactation

- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated

- Participation in another medical investigation or trial within 30 days of
randomization

- Known allergy to ranibizumab

- Acute cardiovascular event requiring hospitalization within the past 3 months

- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or
anticipated use during the study

- Macular edema is considered to be due to a cause other than DME

- An ocular condition is present such that, in the opinion of the investigator, visual
acuity loss would not improve from the resolution of macular edema

- History of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agent
other than bevacizumab within 9 months prior to randomization

- History of panretinal photocoagulation within 3 months prior to randomization or
anticipated need for panretinal photocoagulation in the 6 months following
randomization

- Yag capsulotomy performed within 1 month prior to randomization

- External ocular infection including conjunctivitis, significant blepharitis, etc.