Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema

Inclusion Criteria:

- CSME and Diagnosis of diabetes mellitus

- Able and willing to provide informed consent prior to any study-related procedures

- Central foveal thickness > 250 microns at baseline

- Best corrected visual acuity between 20/400 and 20/40

- Willing and able to comply with clinic visits and study-related procedures

- U.S. patients will be required to have a Health Insurance Portability and
Accountability Act (HIPAA) authorization; in other countries, as applicable according
to national laws

Exclusion Criteria:

- - Macular edema is considered to be due to a cause other than diabetic macular edema.

- An ocular condition is present such that, in the opinion of the investigator, visual
acuity loss would not improve from resolution of macular edema (e.g., macular
ischemia, vitreomacular traction, foveal atrophy, pigment abnormalities, dense
subfoveal hard exudates, nonretinal condition).

- An ocular condition is present (other than diabetes) that, in the opinion of the
investigator, might affect macular edema or alter visual acuity during the course of
the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease,
neovascular glaucoma, etc.)

- Substantial cataract that, in the opinion of the investigator, is likely to be
decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity
to 20/40 or worse if eye was otherwise normal).

- History of treatment for diabetic macular edema at any time in the past 4 months
(such as focal/grid macular photocoagulation, intravitreal or peribulbar
corticosteroids, anti-VEGF drugs, or any other treatment).

- History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to
enrollment.

- History of major ocular surgery (including vitrectomy, cataract extraction, scleral
buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within
the next 6 months following randomization. 13

- History of YAG capsulotomy performed within 2 months prior to randomization.

- Aphakia.

- Intraocular pressure >= 25 mmHg.

- History of open-angle glaucoma (either primary open-angle glaucoma or other cause of
open-angle glaucoma; note: history of angle-closure glaucoma is not an exclusion
criterion).

- History of steroid-induced intraocular pressure (IOP) elevation that required
IOP-lowering treatment.

- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or
significant blepharitis

- Significant renal disease, defined as a history of chronic renal failure requiring
dialysis or kidney transplant.

- A condition that, in the opinion of the investigator, would preclude participation in
the study (e.g., unstable medical status including blood pressure, cardiovascular
disease, and glycemic control)

- Participation in an investigational trial within 30 days of randomization that
involved treatment with any drug that has not received regulatory approval at the
time of study entry

- Known allergy to any component of the study drug

- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).

- Major surgery within 28 days prior to randomization or major surgery planned during
the next 6 months.

- Myocardial infarction, other cardiac event requiring hospitalization, stroke,
transient ischemic attack, or treatment for acute congestive heart failure within 4
months prior to randomization.

- Systemic anti-vascular growth factor (anti-VEGF) or pro-VEGF treatment within 4
months prior to randomization 14

- For women of child-bearing potential: pregnant or lactating or intending to become
pregnant within the next 12 months.

- Subject is expecting to move out of the area of the clinical center to an area not
covered by another clinical center during the first 12 months of the study.