Diabetic Macular EdemaNCT02000102
Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab
An observational study of Diabetic Macular Edema, run by Stanford University at 1 site in United States.
Trial summary
Patients with diabetic macular edema who were switched to aflibercept after having been treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual acuity and anatomic outcomes. 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 Injection of Aflibercept
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford
Palo Alto, California, 94303
About this study
Patients with diabetic macular edema who were switched to aflibercept after having been treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual acuity and anatomic outcomes.
- Conditions
- Diabetic Macular Edema
- Being tested
- Intravitreal Injection of Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Injection of AfliberceptDrug
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Macular Edema Patients Switched to Aflibercept | Not described Receives: Drug: Intravitreal Injection of Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: 1 year
Secondary outcomes (1)
Central Subfield Thickness on Optical Coherence Tomography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000102
- Sponsor's protocol ID
- 28279
- Status last verified
- Nov 2014
- First submitted
- 26 Nov 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab
- ClinicalTrials.gov ID
- NCT02000102
- Acronym / sponsor ID
- 28279
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with diabetic macular edema who were switched to aflibercept after having been treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual acuity and anatomic outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Macular Edema Patients Switched to Aflibercept | – | Drug: Intravitreal Injection of Aflibercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 Injection of Aflibercept | Drug | Diabetic Macular Edema Patients Switched to Aflibercept |
Primary outcome
Visual Acuity
Time frame: 1 year
1 secondary outcome
Central Subfield Thickness on Optical Coherence Tomography
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Stanford University at 1 site 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 0 inclusion and 1 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 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Acuity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2014.