Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab (ERASER)

California Retina Consultants

Status and phase

Completed

Phase 4

Conditions

Diabetic Macular Edema

Treatments

Drug: Intravitreal ranibizumab 0.3mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02107131

ML29184s

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.