Diabetic Macular EdemaPhase 4NCT03059277
Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab
A Phase 4 study testing Intravitreal Aflibercept in people with Diabetic Macular Edema, run by Southeast Clinical Research Associates, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy of intravitreal aflibercept injections administered in a treat and extend fashion in eyes that have persistent center involved diabetic macular edema following at least 4 intravitreal injections of 0.3 mg ranibizumab over 24 weeks. 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 Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 30 Sep 2020
- 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
- Age ≥18 years with type 1 or type 2 diabetes
- Best Corrected Visual Acuity (by ETDRS) letter score in study eye ≤ 85 and ≥24 (approximate Snellen equivalent 20/20 to 20/320)
- Central retinal thickness on SD OCT at baseline visit of > 300 microns using Heidelberg Spectralis with definite evidence of intraretinal or subretinal fluid due to diabetic retinopathy in the CSF.
- Patients must have received at least four intravitreal ranibizumab 0.3 mg injections within 24 weeks prior to screening and failed to have had complete resolution of intraretinal or subretinal fluid on SD OCT and a CRT > 300 microns using Heidelberg Spectralis
Who cannot join
- Laser photocoagulation (panretinal or macular) in the study within 90 days of baseline
- Active high risk proliferative diabetic retinopathy (PDR)
- History of intravitreal corticosteroids within 4 months of baseline
- History of intravitreal bevacizumab within 24 weeks of baseline
- History of idiopathic or autoimmune uveitis in the study eye
- Cataract surgery in the study eye within 90 days of baseline
Show all 10Show fewer
- Any intraocular surgery within 90 days of baseline
- Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect vision
- Evidence of active infection in either eye
- Uncontrolled glaucoma in the study eye defined as a pressure of > 25 mmHg on maximal medical therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, 28210
Charlotte Eye Ear Nose and Throat Associates, PA
Statesville, North Carolina, 28677
About this study
Official title: Efficacy of Intravitreal Aflibercept Injection (IAI) Administered in a Treat and Extend Fashion in Patients With Center Involved Diabetic Macular Edema (DME) Previously Managed With 0.3 mg Intravitreal Ranibizumab
The purpose of this study is to determine the efficacy of intravitreal aflibercept injections administered in a treat and extend fashion in eyes that have persistent center involved diabetic macular edema following at least 4 intravitreal injections of 0.3 mg ranibizumab over 24 weeks.
Read the detailed description
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial to determine the efficacy of intravitreal aflibercept (IAI) administered in a treat and extend fashion in eyes that have persistent centered involved diabetic macular edema despite at least 4 intravitreal injections of ranibizumab 0.3mg over 24 weeks prior to enrollment. Patients will receive intravitreal injections of aflibercept (2mg/0.05cc) at baseline and monthly until an eye has reached stability defined as: < 10% change in the Spectral Domain Optical Coherence Tomography (SD OCT) central retinal thickness (CRT) reading from the previous 2 visits (can include baseline) and less than a 5 letter decrease in Best Corrected Visual Acuity (BCVA) from best BCVA from prior visits. Once an eye has reached stability criteria, a treat and extend protocol will be used and treatment will be rendered on every visit. The duration between treatments will be extended by 2 weeks from the last visit if SD OCT extension criteria are met: < 10% change in CRT over 2 consecutive visits and < 5 letter decrease in BCVA from baseline
If at any return visit subretinal and/or intraretinal fluid recurs that causes the CRT to increase by > 10 % from its lowest level in the previous 2 consecutive visits, or CRT increases by < 10% due to subretinal and/or intraretinal fluid but is associated with a decrease of BCVA of > 5 letters from baseline then the eye will receive IAI and the treatment interval will be decreased by 1 week. If the eye has not improved or worsened for at least 2 consecutive visits and the SD OCT central subfield thickness is ≥ 300 microns or visual acuity is worse than 20/20, the following will be done:
Prior to the 24-week visit, an injection will be given. At and after the 24-week visit, an injection will be given and modified grid laser can be given at the discretion of the investigator within 7 days of IAI based on rescue criteria
- Conditions
- Diabetic Macular Edema
- Being tested
- Intravitreal Aflibercept
- Keywords
- Diabetic Macular Edema, Diabetes, reduced treatment frequency
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal AfliberceptDrug
Intravitreal Aflibercept 2mg
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Aflibercept | Experimental | Intravitreal Aflibercept Injection (IAI) Receives: Drug: Intravitreal Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Subfield Thickness (CST)
Percentage of patients who experience a > 10% decrease in mean Central Subfield Thickness (CST) from baseline or whose CST < 300 microns at 52 weeks.
Measured: 52 weeks
Secondary outcomes (3)
Mean Change in Visual Acuity
Mean change in Best Corrected Visual Acuity
Measured: 52 weeks
Change in Central Subfield Thickness (CST)
Mean change in CST on SD OCT compared to baseline
Measured: 52 weeks
Number of Intravitreal Injections
Mean number of injections from baseline
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jun 2018 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Why it stopped: Site investigator decided to not move forward with study.
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast Clinical Research Associates, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Andrew N Antoszyk, MD, Principal investigator, Charlotte Eye Ear Nose and Throat Assciates, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059277
- Sponsor's protocol ID
- VGFTe-DME-1432
- Status last verified
- Jun 2018
- First submitted
- 16 Feb 2017
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Site will not be sharing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravitreal Aflibercept Injection (IAI) Administered in a Treat and Extend Fashion in Patients With Center Involved Diabetic Macular Edema (DME) Previously Managed With 0.3 mg Intravitreal Ranibizumab
- ClinicalTrials.gov ID
- NCT03059277
- Acronym / sponsor ID
- VGFTe-DME-1432
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, Diabetes, reduced treatment frequency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site investigator decided to not move forward with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Southeast Clinical Research Associates, LLCUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 23 Feb 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.
The purpose of this study is to determine the efficacy of intravitreal aflibercept injections administered in a treat and extend fashion in eyes that have persistent center involved diabetic macular edema following at least 4 intravitreal injections of 0.3 mg ranibizumab over 24 weeks.
Detailed description
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial to determine the efficacy of intravitreal aflibercept (IAI) administered in a treat and extend fashion in eyes that have persistent centered involved diabetic macular edema despite at least 4 intravitreal injections of ranibizumab 0.3mg over 24 weeks prior to enrollment. Patients will receive intravitreal injections of aflibercept (2mg/0.05cc) at baseline and monthly until an eye has reached stability defined as: < 10% change in the Spectral Domain Optical Coherence Tomography (SD OCT) central retinal thickness (CRT) reading from the previous 2 visits (can include baseline) and less than a 5 letter decrease in Best Corrected Visual Acuity (BCVA) from best BCVA from prior visits. Once an eye has reached stability criteria, a treat and extend protocol will be used and treatment will be rendered on every visit. The duration between treatments will be extended by 2 weeks from the last visit if SD OCT extension criteria are met: < 10% change in CRT over 2 consecutive visits and < 5 letter decrease in BCVA from baseline
If at any return visit subretinal and/or intraretinal fluid recurs that causes the CRT to increase by > 10 % from its lowest level in the previous 2 consecutive visits, or CRT increases by < 10% due to subretinal and/or intraretinal fluid but is associated with a decrease of BCVA of > 5 letters from baseline then the eye will receive IAI and the treatment interval will be decreased by 1 week. If the eye has not improved or worsened for at least 2 consecutive visits and the SD OCT central subfield thickness is ≥ 300 microns or visual acuity is worse than 20/20, the following will be done:
Prior to the 24-week visit, an injection will be given. At and after the 24-week visit, an injection will be given and modified grid laser can be given at the discretion of the investigator within 7 days of IAI based on rescue criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Aflibercept | Experimental | Drug: Intravitreal AfliberceptIntravitreal Aflibercept Injection (IAI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years with type 1 or type 2 diabetes
- Best Corrected Visual Acuity (by ETDRS) letter score in study eye ≤ 85 and ≥24 (approximate Snellen equivalent 20/20 to 20/320)
- Central retinal thickness on SD OCT at baseline visit of > 300 microns using Heidelberg Spectralis with definite evidence of intraretinal or subretinal fluid due to diabetic retinopathy in the CSF.
- Patients must have received at least four intravitreal ranibizumab 0.3 mg injections within 24 weeks prior to screening and failed to have had complete resolution of intraretinal or subretinal fluid on SD OCT and a CRT > 300 microns using Heidelberg Spectralis
Key exclusion criteria (10 listed)
- Laser photocoagulation (panretinal or macular) in the study within 90 days of baseline
- Active high risk proliferative diabetic retinopathy (PDR)
- History of intravitreal corticosteroids within 4 months of baseline
- History of intravitreal bevacizumab within 24 weeks of baseline
- History of idiopathic or autoimmune uveitis in the 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 |
|---|---|---|
| Intravitreal AfliberceptIntravitreal Aflibercept 2mg | Drug | Intravitreal Aflibercept |
Primary outcome
Change in Central Subfield Thickness (CST)
Time frame: 52 weeks
Percentage of patients who experience a > 10% decrease in mean Central Subfield Thickness (CST) from baseline or whose CST < 300 microns at 52 weeks.
3 secondary outcomes
Mean Change in Visual Acuity
Time frame: 52 weeks
Change in Central Subfield Thickness (CST)
Time frame: 52 weeks
Number of Intravitreal Injections
Time frame: 52 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Individual participant dataSharing planned: No. Site will not be sharing IPD.
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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.
Andrew N Antoszyk, MD principal investigator
Charlotte Eye Ear Nose and Throat Assciates, PA
2 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 Aflibercept in people with Diabetic Macular Edema, run by Southeast Clinical Research Associates, LLC at 2 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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was withdrawn before enrolling participants, so there are no results.
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 Central Subfield Thickness (CST) (time frame: 52 weeks). 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 14 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.