Clinical trial NCT02107131: Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab
Official title: Evaluation of ReAding Speed, Contrast Sensitivity, and Work Productivity in Working Individuals With Diabetic Macular Edema Following Treatment With Intravitreal Ranibizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: California Retina Consultants
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: A Change Between Two Time Points is Reported for Maximum Reading Speed
timeFrame: Month 12
Secondary outcomes:
measure: Change in Activity Productivity
timeFrame: Month 12
measure: Change in Visual Acuity
timeFrame: Month 12
measure: Change in Contrast Sensitivity
timeFrame: 12 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: California Retina Consultants - Bakersfield
state: California
city: Oxnard
country: United States
facility: California Retina Consultants
state: California
city: Palmdale
country: United States
facility: California Retina Consultants
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants - Santa Barbara Office
state: California
city: Santa Maria
country: United States
facility: California Retina Consultants
state: California
city: Visalia
country: United States
facility: California Retina Consultants
state: California
Study officials:
affiliation: California Retina Consultants
name: Gabriel Gordon, PhD
role: STUDY_DIRECTOR
References: