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

Phase 4

Completed

Conditions: Diabetic Macular Edema

Interventions: Drug: Intravitreal ranibizumab 0.3mg

Registration Number: NCT02107131

Lead Sponsor: California Retina Consultants

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRN Intravitreal ranibizumab 0.3mg	Intravitreal ranibizumab 0.3mg	PRN Intravitreal ranibizumab 0.3mg injections.
Monthly Intravitreal ranibizumab 0.3mg	Intravitreal ranibizumab 0.3mg	Monthly Intravitreal ranibizumab 0.3mg injections.

Primary Outcome Measures

Name	Time	Method
A Change Between Two Time Points is Reported for Maximum Reading Speed	Month 12	A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed.

Secondary Outcome Measures

Name	Time	Method
Change in Activity Productivity	Month 12	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).
Change in Visual Acuity	Month 12	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.
Change in Contrast Sensitivity	12 months	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 = \[(total # letters correct - 3) x 0.05\].

Trial Locations

Locations (3): California Retina Consultants
🇺🇸
Visalia, California, United States
California Retina Consultants - Santa Barbara Office
🇺🇸
Santa Barbara, California, United States
California Retina Consultants - Bakersfield
🇺🇸
Bakersfield, California, United States