Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab
NCT ID: NCT02107131
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2015-03-13
2017-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monthly Intravitreal ranibizumab 0.3mg
Monthly Intravitreal ranibizumab 0.3mg injections.
Intravitreal ranibizumab 0.3mg
PRN Intravitreal ranibizumab 0.3mg
PRN Intravitreal ranibizumab 0.3mg injections.
Intravitreal ranibizumab 0.3mg
Interventions
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Intravitreal ranibizumab 0.3mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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California Retina Consultants
OTHER
Responsible Party
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Principal Investigators
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Gabriel Gordon, PhD
Role: STUDY_DIRECTOR
California Retina Consultants
Locations
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California Retina Consultants - Bakersfield
Bakersfield, California, United States
California Retina Consultants
Oxnard, California, United States
California Retina Consultants
Palmdale, California, United States
California Retina Consultants - Santa Barbara Office
Santa Barbara, California, United States
California Retina Consultants
Santa Maria, California, United States
California Retina Consultants
Visalia, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ML29184s
Identifier Type: -
Identifier Source: org_study_id