Diabetic Macular EdemaNCT03297684
Assessment of Biomarker Profile in Diabetic Macular Edema With Intravitreal Aflibercept Injection
An observational study of Diabetic Macular Edema, run by Advanced Eye Research Associates at 1 site in United States.
Trial summary
To assess the biomarker profile in diabetic macular edema patients in response to intravitreal aflibercept injection. Patients with diabetic macular edema who meet study requirements will receive monthly intravitreal injections of aflibercept as approved by FDA for a period of 6 months. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Aflibercept Injection [Eylea]
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 31 Dec 2022
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals with DME from the Dartmouth, MA geographic area who are patients of Advanced Eye Centers
Who may be able to join
- Current diagnosis type 1 or type 2 diabetes
- Clinical DME as assessed by OCT
- Well controlled glaucoma on medications but not on prostaglandin analogues
- Mild Age Related Macular Degeneration (AMD)
- Visual acuity between 73 and 5 ETDRS letters (20/40 -20/800 on eye chart)
- Willing and able to participate and to comply with clinic visits and procedures
- Provide signed informed consent
Who cannot join
- Unwillingness to participate or inability to understand or sign informed consent
- Poor eye fluid that would preclude adequate testing
- Prior intraocular treatment with anti-VEGF or focal laser treatment within 90 days
- Corticosteroid injections within 120 days
- Active proliferative diabetic retinopathy
- Intraocular pressure greater than 25 mm Hg
Show all 14Show fewer
- Any previous vitrectomy surgery
- Current use of systemic anti-VEGF agents
- Shallow anterior eye chamber in eye with natural lens
- Non-diabetic related macular swelling (retinal vein occlusion)
- History of ocular disease
- Systemic disease other than diabetes mellitus
- Pregnant or breast feeding women
- Sexually active men or women of childbearing potential who are unwilling to practice adequate birth control during study
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Eye Centers
South Dartmouth, Massachusetts, 02747
About this study
Official title: Assessment of Biomarker Profile in Diabetic Macular Edema in Response to Treatment With Intravitreal Aflibercept
To assess the biomarker profile in diabetic macular edema patients in response to intravitreal aflibercept injection. Patients with diabetic macular edema who meet study requirements will receive monthly intravitreal injections of aflibercept as approved by FDA for a period of 6 months. A small quantity of fluid will be removed from the vitreous at each injection for laboratory evaluation of biomarkers present before, during and after treatment with aflibercept.
Read the detailed description
Study objective is to better understand the pathophysiology of diabetic macular edema (DME) by defining the factors that participate in the disease process or may be good biomarkers for disease progression. Study will investigate the temporal relationship between the course of treatment with anti-VEGF therapy and levels of candidate biomarkers previously identified to determine which biomarkers are affected by anti-VEGF therapy with aflibercept. Study will correlate response to therapy to particular biomarkers and attempt to identify those associated with resistance to therapy for DME. Biomarker data will be correlated with serial clinical evaluation of disease progression. 40 subjects with clinically significant DME who plan to undergo anti-VEGF therapy will be treated with intravitreal aflibercept monthly for 6 months. At each visit aqueous humor will be collected and stored (6 samples per patient). At termination of study all specimens will be analyzed for biomarkers identified from previous studies.
- Conditions
- Diabetic Macular Edema
- Being tested
- Aflibercept Injection [Eylea]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept Injection [Eylea]Drug
Intravitreal injection aflibercept
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure biomarkers in aqueous humor from individuals with DME
Identify temporal effects of treatment with intravitreal afflibercept
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start11 Apr 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Eye Research Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary M Chatterton, MBA, JD, Study director, Advanced Eye Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297684
- Sponsor's protocol ID
- AERA101
- Status last verified
- Feb 2022
- First submitted
- 27 Sep 2017
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Biomarker Profile in Diabetic Macular Edema in Response to Treatment With Intravitreal Aflibercept
- ClinicalTrials.gov ID
- NCT03297684
- Acronym / sponsor ID
- AERA101
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Advanced Eye Research AssociatesIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Sep 2017 (actual)
- 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.
To assess the biomarker profile in diabetic macular edema patients in response to intravitreal aflibercept injection. Patients with diabetic macular edema who meet study requirements will receive monthly intravitreal injections of aflibercept as approved by FDA for a period of 6 months. A small quantity of fluid will be removed from the vitreous at each injection for laboratory evaluation of biomarkers present before, during and after treatment with aflibercept.
Detailed description
Study objective is to better understand the pathophysiology of diabetic macular edema (DME) by defining the factors that participate in the disease process or may be good biomarkers for disease progression. Study will investigate the temporal relationship between the course of treatment with anti-VEGF therapy and levels of candidate biomarkers previously identified to determine which biomarkers are affected by anti-VEGF therapy with aflibercept. Study will correlate response to therapy to particular biomarkers and attempt to identify those associated with resistance to therapy for DME. Biomarker data will be correlated with serial clinical evaluation of disease progression. 40 subjects with clinically significant DME who plan to undergo anti-VEGF therapy will be treated with intravitreal aflibercept monthly for 6 months. At each visit aqueous humor will be collected and stored (6 samples per patient). At termination of study all specimens will be analyzed for biomarkers identified from previous studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with DME from the Dartmouth, MA geographic area who are patients of Advanced Eye Centers
Key inclusion criteria (7 listed)
- Current diagnosis type 1 or type 2 diabetes
- Clinical DME as assessed by OCT
- Well controlled glaucoma on medications but not on prostaglandin analogues
- Mild Age Related Macular Degeneration (AMD)
- Visual acuity between 73 and 5 ETDRS letters (20/40 -20/800 on eye chart)
Key exclusion criteria (14 listed)
- Unwillingness to participate or inability to understand or sign informed consent
- Poor eye fluid that would preclude adequate testing
- Prior intraocular treatment with anti-VEGF or focal laser treatment within 90 days
- Corticosteroid injections within 120 days
- Active proliferative diabetic retinopathy
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 |
|---|---|---|
| Aflibercept Injection [Eylea]Intravitreal injection aflibercept | Drug | – |
Primary outcome
Measure biomarkers in aqueous humor from individuals with DME
Time frame: 2 years
Identify temporal effects of treatment with intravitreal afflibercept
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Mary M Chatterton, MBA, JD study director
Advanced Eye Research Associates
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 Advanced Eye Research Associates 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. 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?
Results are not available in the source record.
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?
Measure biomarkers in aqueous humor from individuals with DME (time frame: 2 years). 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 Feb 2022.