Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Intervention: Intravitreal ranibizumab 0.3mg
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on
      day-to-day visual function in patients with Diabetic Macular Edema (DME).
    

Eligibility criteria:

        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.