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

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of ReAding Speed, Contrast Sensitivity, and Work Productivity in Working Individuals With Diabetic Macular Edema Following Treatment With Intravitreal Ranibizumab

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Intravitreal ranibizumab 0.3mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monthly Intravitreal ranibizumab 0.3mg<br>Monthly Intravitreal ranibizumab 0.3mg injections. | Drug: Intravitreal ranibizumab 0.3mg<br> <br> |
| Active Comparator: PRN Intravitreal ranibizumab 0.3mg<br>PRN Intravitreal ranibizumab 0.3mg injections. | Drug: Intravitreal ranibizumab 0.3mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Change Between Two Time Points is Reported for Maximum Reading Speed | A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Activity Productivity | To evaluate the mean change in activity impairment from baseline to 12 months using and activity impairment questionnaire. Scale is from 0-10 with 0 being lowest (no effect on my daily activities) and 10 being highest (completely prevented me from doing my daily activities). | Month 12 | 
| Change in Visual Acuity | To determine the mean change in best-corrected visual acuity on ETDRS visual acuity chart at a starting distance of 4 meters from baseline. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning. | Month 12 | 
| Change in Contrast Sensitivity | To measure the mean change in contrast sensitivity scores on Pelli-Robson charts from baseline. Scale in assessing the log of the contract sensitivity score (CS score) is from 0-2.25, with 0 being no letters read on the contrast sensitivity chart, and 2.25 being all letters read on the contrast sensitivity chart. Total CS score = [(total # letters correct - 3) x 0.05]. | 12 months |