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

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Intravitreal ranibizumab 0.3mg

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93039
      • California Retina Consultants - Bakersfield
    • Oxnard, California, United States, 93454
      • California Retina Consultants
    • Palmdale, California, United States, 93551
      • California Retina Consultants
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants - Santa Barbara Office
    • Santa Maria, California, United States, 93454
      • California Retina Consultants
    • Visalia, California, United States, 93277
      • California Retina Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Monthly Intravitreal ranibizumab 0.3mg; Monthly Intravitreal ranibizumab 0.3mg injections.	Drug: Intravitreal ranibizumab 0.3mg
ACTIVE_COMPARATOR: PRN Intravitreal ranibizumab 0.3mg; PRN Intravitreal ranibizumab 0.3mg injections.	Drug: Intravitreal ranibizumab 0.3mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: California Retina Consultants
• Investigators: Study Director: Gabriel Gordon, PhD, California Retina Consultants

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2015
• Primary Completion (ACTUAL): May 15, 2017
• Study Completion (ACTUAL): May 15, 2017

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (ESTIMATE): April 8, 2014

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: ML29184s