We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02107131
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
California Retina Consultants

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Intravitreal ranibizumab 0.3mg Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of ReAding Speed, Contrast Sensitivity, and Work Productivity in Working Individuals With Diabetic Macular Edema Following Treatment With Intravitreal Ranibizumab
Actual Study Start Date : March 13, 2015
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. A Change Between Two Time Points is Reported for Maximum Reading Speed [ Time Frame: Month 12 ]
    A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed.


Secondary Outcome Measures :
  1. Change in Activity Productivity [ Time Frame: 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).

  2. Change in Visual Acuity [ Time Frame: 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.

  3. Change in Contrast Sensitivity [ Time Frame: 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].


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107131


Locations
Layout table for location information
United States, California
California Retina Consultants - Bakersfield
Bakersfield, California, United States, 93039
California Retina Consultants
Oxnard, California, United States, 93454
California Retina Consultants
Palmdale, California, United States, 93551
California Retina Consultants - Santa Barbara Office
Santa Barbara, California, United States, 93103
California Retina Consultants
Santa Maria, California, United States, 93454
California Retina Consultants
Visalia, California, United States, 93277
Sponsors and Collaborators
California Retina Consultants
Investigators
Layout table for investigator information
Study Director: Gabriel Gordon, PhD California Retina Consultants
  Study Documents (Full-Text)

Documents provided by California Retina Consultants:
Study Protocol and Statistical Analysis Plan  [PDF] December 4, 2015

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: California Retina Consultants
ClinicalTrials.gov Identifier: NCT02107131    
Other Study ID Numbers: ML29184s
First Posted: April 8, 2014    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Degeneration
Retinal Diseases
Macular Edema
Macular Degeneration
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents