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

Diabetic Macular Edema Clinical Trial

— ERASER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107131
• Other study ID #: ML29184s
• Status: Completed
• Phase: Phase 4
• Start date: March 13, 2015
• Est. completion date: May 15, 2017

Study information

• Verified date: November 2018
• Source: California Retina Consultants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• Intravitreal ranibizumab 0.3mg

Locations

Country	Name	City	State
United States	California Retina Consultants - Bakersfield	Bakersfield	California
United States	California Retina Consultants	Oxnard	California
United States	California Retina Consultants	Palmdale	California
United States	California Retina Consultants - Santa Barbara Office	Santa Barbara	California
United States	California Retina Consultants	Santa Maria	California
United States	California Retina Consultants	Visalia	California

Sponsors (1)

Lead Sponsor	Collaborator
California Retina Consultants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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