Diabetic Macular EdemaPhase 4ERASERNCT02107131

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

A Phase 4 study testing Intravitreal ranibizumab 0.3mg in people with Diabetic Macular Edema, run by California Retina Consultants at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Macular Edema
What is being tested?: Intravitreal ranibizumab 0.3mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 6 sitesUnited States
Study dates: 13 Mar 2015to 15 May 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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)

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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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

Official title: 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).

Conditions: Diabetic Macular Edema
Being tested: Intravitreal ranibizumab 0.3mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravitreal ranibizumab 0.3mgDrug

Study groups in NCT02107131
Study group	Role	What they receive
Monthly Intravitreal ranibizumab 0.3mg	Active comparator	Monthly Intravitreal ranibizumab 0.3mg injections. Receives: Drug: Intravitreal ranibizumab 0.3mg
PRN Intravitreal ranibizumab 0.3mg	Active comparator	PRN Intravitreal ranibizumab 0.3mg injections. Receives: Drug: Intravitreal ranibizumab 0.3mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Month 12

Secondary outcomes (3)

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).
Measured: 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.
Measured: 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].
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201515 May 2017

First posted8 Apr 2014 (estimated)
Study start13 Mar 2015
Primary completion15 May 2017
Study completion15 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02107131
Sponsor's protocol ID: ML29184s
Acronym: ERASER
Status last verified: Nov 2018
First submitted: 2 Apr 2014
Last updated: 19 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of ReAding Speed, Contrast Sensitivity, and Work Productivity in Working Individuals With Diabetic Macular Edema Following Treatment With Intravitreal Ranibizumab
ClinicalTrials.gov ID: NCT02107131
Acronym / sponsor ID: ERASER / ML29184s
Conditions: Diabetic Macular Edema
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: California Retina ConsultantsUniversity, hospital or other
Study start: 13 Mar 2015 (actual)
Primary completion: 15 May 2017 (actual)
Study completion: 15 May 2017 (actual)
First posted: 8 Apr 2014 (estimated)
Results: Posted 19 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Monthly Intravitreal ranibizumab 0.3mg	Active comparator	Drug: Intravitreal ranibizumab 0.3mgMonthly Intravitreal ranibizumab 0.3mg injections.
PRN Intravitreal ranibizumab 0.3mg	Active comparator	Drug: Intravitreal ranibizumab 0.3mgPRN Intravitreal ranibizumab 0.3mg injections.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravitreal ranibizumab 0.3mg	Drug	Monthly Intravitreal ranibizumab 0.3mg, PRN Intravitreal ranibizumab 0.3mg

Primary outcome

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.

3 secondary outcomes

Change in Activity Productivity
Time frame: Month 12
Change in Visual Acuity
Time frame: Month 12
Change in Contrast Sensitivity
Time frame: 12 months

Results and safety

Results posted to the registry on 19 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Monthly	20	12
PRN Group	20	11

Primary outcome: A Change Between Two Time Points is Reported for Maximum Reading Speed

Time frame: Month 12. Mean (Standard Deviation). Unit: words per minute

Measure	Monthly n = 12	PRN Group n = 11
Value	161.94 (43.56)	167.65 (32.30)

Population analysed: MNREAD words per minute

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Monthly	5 of 20 (25%)	15 of 20 (75%)	0 of 20
PRN Group	4 of 20 (20%)	8 of 20 (40%)	1 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gabriel Gordon, PhD study director

California Retina Consultants

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravitreal ranibizumab 0.3mg in people with Diabetic Macular Edema, run by California Retina Consultants at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A Change Between Two Time Points is Reported for Maximum Reading Speed (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.