Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab

Inclusion Criteria:

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

- Age 18 ≤ x ≤ 65 years and currently employed at the baseline study visit

- Diagnosis of diabetes mellitus (type 1 or 2)

o Any one of the following will be considered to be sufficient evidence that diabetes
is present:

- Current regular use of insulin for treatment of diabetes

- Current regular use of oral anti-hyperglycemia agent for the treatment of diabetes

- Clinical evidence of retinal thickening due to macular edema involving the center of
the macula, associated with diabetic retinopathy.

- Central diabetic macular edema present on clinical examination or or evidence
indicating disease activity on spectral domain OCT.

- Visual acuity score greater than or equal to 19 letters (20/400) and less than or
equal to 73 letters (20/40) by the ETDRS visual acuity protocol.

- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT
testing and retinal photography

Exclusion Criteria:

- Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women
not using adequate contraception.

- Participation in another ocular investigation or trial simultaneously

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

- Any condition that, in the opinion of the investigator, would preclude participation
in the study (e.g. chronic alcoholism, drug abuse)

- Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be
contributing to the macular edema

- An eye that, in the investigator's opinion, has no chance of improving in visual
acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or
geographic atrophy)

- Presence of another ocular condition that may affect the visual acuity or macular
edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)

- Evidence of active neovascularization of the iris or retina

- Evidence of central atrophy or fibrosis in the study eye

- Presence of substantial cataract, one that might decrease the vision by 3 or more
lines of vision at sometime during the study.

- Previous use of intraocular or periocular corticosteroids in the study eye in the
previous 120 days

- Previous treatment with anti-angiogenic drugs in the study eye i.e. pegaptanib sodium,
bevacizumab, ranibizumab, aflibercept within 120 days prior to baseline

- History of vitreous surgery in the study eye

- History of cataract surgery within 3 months of enrollment.

- History of YAG capsulotomy within 2 months of enrollment.

- Visual acuity <20/400 in the fellow eye

- Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications.

- History of cerebral vascular accident or myocardial infarction within 3 months prior
to Day 0.