Diabetic Macular EdemaPhase 4NCT02441907
Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Diabetic Macular Edema
A Phase 4 study testing aflibercept in people with Diabetic Macular Edema, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye. This condition can develop in diabetics where swelling results from leaking of fluid from the blood vessels of the eye, into the center of the… 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?
- aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Sep 2019
- Phase
- Phase 4
- 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
Who may be able to join
- Male or female aged 18 years or above
- Presence of Non Proliferative Diabetic Retinopathy (NPDR)
- Treatment Naïve patients with DME with central macular thickness of 310μm or more on SD-OCT (cirrus)
- Subjects with Type I or II diabetes mellitis
- Willing and able to provide informed consent for participation in the study
Who cannot join
- Proliferative diabetic retinopathy in the study eye or PRP within the last 12 months or anticipated PRP in the next 6 months
- Uncontrolled glaucoma
- History of intraocular surgery within 3 months in the study eye
- History of vitrectomy surgery
- Laser treatment within 3 months of study eye
- Vitreomacular traction, epiretinal membrane or any other maculopathy in the study eye
Show all 15Show fewer
- Prior intravitreal injection within the past 6 months
- Known allergy to the study drug or fluorescein
- History of stroke or AMI within 6 months of enrollment
- Patients receiving dialysis for renal failure
- Patients currently on systemic immunosuppression
- Patients on two or more class of medication for glaucoma in study eye
- Patients with tuberculosis
- Patients who are pregnant.
- Unwilling or unable to follow or comply with all study related procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Treatment Naïve Patients With Diabetic Macular Edema
Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye. This condition can develop in diabetics where swelling results from leaking of fluid from the blood vessels of the eye, into the center of the retina, the macula. If left untreated, this can affect central vision. The current standard treatment for diabetic macular edema includes medications injected directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are injected directly into the eye are known as anti-Vascular Endothelial Growth Factor (anti-VEGF) agents which help to reduce the leaking. However, response in patients to these anti-VEGF drugs can vary and examination of predictive factors is required. This particular study examines cellular factors called cytokines in patients receiving aflibercept, a type of anti-VEGF drug, in the hopes of detecting changes in cytokines that can predict treatment response amongst groups of patients.
- Conditions
- Diabetic Macular Edema
- Being tested
- aflibercept
- Keywords
- Diabetic Macular Edema, Ocular Cytokines, Triamcinolone Acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
afliberceptDrug
Also called Eylea
| Study group | Role | What they receive |
|---|---|---|
| aflibercept treatment | Other | aflibercept, 40 mg/mL Solution for Intravitreal Injection Receives: Drug: aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months
Measured: 3 months
Secondary outcomes (1)
Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018
- Study completionSep 2019
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 Unity Health TorontoThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajeev Muni, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441907
- Sponsor's protocol ID
- Aflibercept Cytokine DME
- Status last verified
- Sep 2019
- First submitted
- 8 May 2015
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Treatment Naïve Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02441907
- Acronym / sponsor ID
- Aflibercept Cytokine DME
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, Ocular Cytokines, Triamcinolone Acetonide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 12 May 2015 (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.
Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye. This condition can develop in diabetics where swelling results from leaking of fluid from the blood vessels of the eye, into the center of the retina, the macula. If left untreated, this can affect central vision. The current standard treatment for diabetic macular edema includes medications injected directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are injected directly into the eye are known as anti-Vascular Endothelial Growth Factor (anti-VEGF) agents which help to reduce the leaking. However, response in patients to these anti-VEGF drugs can vary and examination of predictive factors is required. This particular study examines cellular factors called cytokines in patients receiving aflibercept, a type of anti-VEGF drug, in the hopes of detecting changes in cytokines that can predict treatment response amongst groups of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aflibercept treatment | Other | Drug: afliberceptaflibercept, 40 mg/mL Solution for Intravitreal Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 years or above
- Presence of Non Proliferative Diabetic Retinopathy (NPDR)
- Treatment Naïve patients with DME with central macular thickness of 310μm or more on SD-OCT (cirrus)
- Subjects with Type I or II diabetes mellitis
- Willing and able to provide informed consent for participation in the study
Key exclusion criteria (15 listed)
- Proliferative diabetic retinopathy in the study eye or PRP within the last 12 months or anticipated PRP in the next 6 months
- Uncontrolled glaucoma
- History of intraocular surgery within 3 months in the study eye
- History of vitrectomy surgery
- Laser treatment within 3 months of study eye
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 |
|---|---|---|
| afliberceptAlso: Eylea | Drug | aflibercept treatment |
Primary outcome
Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months
Time frame: 3 months
1 secondary outcome
Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept
Time frame: 3 months
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 19 Sep 2019.
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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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.
Rajeev Muni, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aflibercept in people with Diabetic Macular Edema, run by Unity Health Toronto at 1 site in Canada.
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 5 inclusion and 15 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 Sep 2019. 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 Canada. 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?
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?
Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months (time frame: 3 months). 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 19 Sep 2019.