Diabetic Macular EdemaPhase 4ROTATEDNCT03340610
IAI for Persistent DME After Treatment With Bevacizumab And Ranibizumab
A Phase 4 study testing Alflibercept in people with Diabetic Macular Edema, run by Southeast Retina Center, Georgia at 1 site in United States.
Trial summary
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly Intravitreal Aflibercept (IAI) doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Alflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 12 Dec 2018
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A patient must meet the following criteria to be eligible for inclusion in the study:
- 1. Adults with Diabetes Mellitus 2. Documented history of ROTATE study completion (within 3 months +/- 1 week of exit visit) 3. BCVA ETDRS visual acuity letter score 20/25-20/400 4. Thickening due to DME involving the center of the macula evident on clinical exam 5. DME on OCT at baseline (>305 microns if male or >290 microns if female) as assessed on Heidelberg Spectralis SD OCT 6. At least 30 days but less than 45 days since prior 0.3 mg ranibizumab injection 7. Willing and able to comply with clinic visits and study-related procedures 8. Provide signed HIPAA statement and informed consent prior to any study procedures
- -
Who cannot join
- A patient who meets any of the following criteria will be excluded from the study:
- Macular edema considered to be due to a cause other than DME (ERM, Vein Occlusion, Postop CME, uveitis)
- History of PRP within 3 months prior to enrollment or anticipated need for PRP
- History of idiopathic or autoimmune uveitis in the study eye
- Cataract surgery in the study eye within 90 days of baseline
- Any intraocular surgery within 90 days of baseline
Show all 20Show fewer
- Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect vision
- Clinically significant pre-retinal fibrosis involving the macula in the study eye per investigator judgment
- Intraocular inflammation of trace or above in the study eye
- Evidence of active infection in either eye
- Uncontrolled glaucoma in the study eye defined as a pressure of > 25 on maximal medical therapy.
- Concurrent disease in the study eye, other than DME, that could compromise VA, require medical or surgical intervention during the study or could confound interpretation of the results
- Ocular media of insufficient quality to obtain fundus and OCT images
- Current treatment for a serious systemic infection
- Administration of systemic anti-angiogenic agents within 180 days of screen
- History of yag capsulotomy within 1 month prior to enrollment
- Receipt of any treatment for DME, other than ranibizumab 0.3 mg, in the study eye at any time in the past 3 months following ROTATE study exit, (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids or other anti-VEGF agents such as Macugen, 2 mg IAI,, 0.5 mg ranibizumab, or intravitreal bevacizumab)
- Any women who are pregnant, breast-feeding, or attempting to become pregnant
- Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
- Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravitreal Alflibercept Injection (IAI) for Persistent Diabetic Macular Edema (DME) After Treatment With Bevacizumab And Ranibizumab
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly Intravitreal Aflibercept (IAI) doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled.
Read the detailed description
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled.
Starting at week 24, patients may be eligible to receive additional 2mg IAI (2q4) treatment if both of the following criteria is met and the investigator feels additional treatment would be beneficial:
- Loss of >5 letters from baseline or best previously recorded best corrected visual acuity (BCVA)
- Presence of new or recurrent intraretinal fluid or subretinal fluid as assessed by SD OCT
Starting at week 24, rescue therapy with macular laser photocoagulation may be administered if any the following criteria are met
- Loss of > 15 letters from baseline or best previously recorded BCVA and loss of acuity felt to be secondary to Diabetic Macular Edema (DME) and not from other cause (i.e., cataract, epiretinal membrane, vitreous hemorrhage, etc) and investigator feels patient would benefit from rescue therapy
- Increase in SD OCT CSF > 100 um from baseline or best previously recorded SD OCT CSF and investigator feels patient would benefit from rescue therapy.
Every 4 week visit will include ETDRS BCVA, IOP measurement, Slit lamp biomicroscopy, Indirect ophthalmoscopy, Heidelberg Spectralis SD-OCT and evaluation for systemic and ocular adverse events. Fundus Photography and Wide field Optos fluorescein angiography will be performed at baseline and at week 20and week 52.
STUDY DURATION: Approximately 52 weeks to the end of the study. Primary endpoint will be evaluated at week 52.
- Conditions
- Diabetic Macular Edema
- Being tested
- Alflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfliberceptDrug
Also called Eylea
Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| Open Label Single Arm Trial | Other | Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab Receives: Drug: Alflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Macular Edema
Reduction in macular edema measured as
- Proportion of eyes with baseline SD OCT CST >350 um demonstrating >15% reduction at week 52 from baseline
- Proportion of eyes that demonstrate SD OCT CST <305um (males) and <290 um (females) at week 52 from baseline
Measured: 52 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study startJun 2015
- Primary completionDec 2018
- Study completion12 Dec 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast Retina Center, Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis M Marcus, MD, Principal investigator, Southeast Retina Center, PC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340610
- Sponsor's protocol ID
- VGFTe-DME-1519
- Acronym
- ROTATED
- Status last verified
- May 2019
- First submitted
- 8 Nov 2017
- Last updated
- 24 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Alflibercept Injection (IAI) for Persistent Diabetic Macular Edema (DME) After Treatment With Bevacizumab And Ranibizumab
- ClinicalTrials.gov ID
- NCT03340610
- Acronym / sponsor ID
- ROTATED / VGFTe-DME-1519
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Southeast Retina Center, GeorgiaUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 1 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly Intravitreal Aflibercept (IAI) doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled.
Detailed description
This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled.
Starting at week 24, patients may be eligible to receive additional 2mg IAI (2q4) treatment if both of the following criteria is met and the investigator feels additional treatment would be beneficial:
- Loss of >5 letters from baseline or best previously recorded best corrected visual acuity (BCVA)
- Presence of new or recurrent intraretinal fluid or subretinal fluid as assessed by SD OCT
Starting at week 24, rescue therapy with macular laser photocoagulation may be administered if any the following criteria are met
- Loss of > 15 letters from baseline or best previously recorded BCVA and loss of acuity felt to be secondary to Diabetic Macular Edema (DME) and not from other cause (i.e., cataract, epiretinal membrane, vitreous hemorrhage, etc) and investigator feels patient would benefit from rescue therapy
- Increase in SD OCT CSF > 100 um from baseline or best previously recorded SD OCT CSF and investigator feels patient would benefit from rescue therapy.
Every 4 week visit will include ETDRS BCVA, IOP measurement, Slit lamp biomicroscopy, Indirect ophthalmoscopy, Heidelberg Spectralis SD-OCT and evaluation for systemic and ocular adverse events. Fundus Photography and Wide field Optos fluorescein angiography will be performed at baseline and at week 20and week 52.
STUDY DURATION: Approximately 52 weeks to the end of the study. Primary endpoint will be evaluated at week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Single Arm Trial | Other | Drug: AlfliberceptEvaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Adults with Diabetes Mellitus 2. Documented history of ROTATE study completion (within 3 months +/- 1 week of exit visit) 3. BCVA ETDRS visual acuity letter score 20/25-20/400 4. Thickening due to DME involving the center of the macula evident on clinical exam 5. DME on OCT at baseline (>305 microns if male or >290 microns if female) as assessed on Heidelberg Spectralis SD OCT 6. At least 30 days but less than 45 days since prior 0.3 mg ranibizumab injection 7. Willing and able to comply with clinic visits and study-related procedures 8. Provide signed HIPAA statement and informed consent prior to any study procedures
- -
Key exclusion criteria (20 listed)
- Macular edema considered to be due to a cause other than DME (ERM, Vein Occlusion, Postop CME, uveitis)
- History of PRP within 3 months prior to enrollment or anticipated need for PRP
- History of idiopathic or autoimmune uveitis in the study eye
- Cataract surgery in the study eye within 90 days of baseline
- Any intraocular surgery within 90 days of baseline
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 |
|---|---|---|
| AlfliberceptAlso: EyleaIntravitreal Injection | Drug | Open Label Single Arm Trial |
Primary outcome
Reduction in Macular Edema
Time frame: 52 weeks from baseline
Reduction in macular edema measured as * Proportion of eyes with baseline SD OCT CST >350 um demonstrating >15% reduction at week 52 from baseline * Proportion of eyes that demonstrate SD OCT CST <305um (males) and <290 um (females) at week 52 from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dennis M Marcus, MD principal investigator
Southeast Retina Center, PC.
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 Alflibercept in people with Diabetic Macular Edema, run by Southeast Retina Center, Georgia 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 3 inclusion and 20 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 24 May 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 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 1 May 2019). 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?
Reduction in Macular Edema (time frame: 52 weeks from baseline). 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 24 May 2019.