Diabetic Macular EdemaAVOCTNCT03394573
Comparison of VA Guided Versus OCT Guided TER Using Aflibercept for Diabetic Macular Edema (AVOCT Study)
An observational study of Diabetic Macular Edema, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This study will evaluate the effectiveness of aflibercept (Eylea®) using two different treatment protocols in patients with vision loss from diabetic macular edema. While one group will be treated with an optical coherence tomography (OCT) guided 'treat and extend' regimen, the other group will be treated according to… 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?
- OCT guided treatment arm and VA guided treatment arm
- Type of treatment
- Injection or infusion
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Sep 2017to 1 Feb 2021
- 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: Patients with vision loss due to diabetic macular edema
Who may be able to join
- General:
- Informed consent as documented by signature of the patient on the informed consent form.
- Male or female, ≥ 18 years of age.
- Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines).
- No relevant change in medication for the management of diabetes within 3 months prior to randomization.
- Patients fulfilling criteria specified in the respective SmPC for aflibercept for the treatment of DME
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- Study eye:
- Visual impairment due to focal or diffuse DME in at least one eye. If both eyes are eligible, the eye with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment.
- BCVA score between 78 and 39 letters using ETDRS- visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) Decrease in vision and CRT due to DME and not due to other causes, at the investigators discretion
Who cannot join
- General:
- Inability to comply with study or follow-up procedures.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, not using or not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases.(Female participants who are surgically sterilised/ hysterectomised, or post-menopausal for longer than 2 years are not considered as being of child-bearing potential.)
- Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree.
- Stroke or myocardial infarction less than 3 months prior to the date of informed consent signature.
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- Known hypersensitivity to aflibercept or any component of the aflibercept formulation. Any other reason that would prevent treatment with aflibercept specified in the SmPC
- Current use of any systemic anti- VEGF drugs [e.g., bevacizumab (Avastin®)].
- Use of other investigational drugs at screening visit.
- Both eyes:
- Any active ocular infection or inflammation (scleritis, uveitis, endophthalmitis) at the time of screening or baseline.
- Uncontrolled glaucoma [intraocular pressure (IOP) ≥30 mmHg on medication or according to Investigator's judgment] at the time of screening or baseline.
- Neovascularisation of the iris or neovascular glaucoma at the time of screening or baseline.
- Intravitreal corticosteroids administered within 3 months prior to the date of informed consent signature.
- Study eye:
- Visually significant cataract, vitreous hemorrhage, rhegmatogenous retinal detachment or age related macular degeneration
- Intraocular treatment with any anti-VEGF drug or intravitreal corticosteroids prior to the date of informed consent signature.
- Inability of obtaining SD-OCT images of sufficient quality to be analysed
- Any intraocular procedure anticipated within the next 6 months following the date of informed consent signature
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital Bern, Department of Ophthalmology
Bern, 3010
About this study
Official title: A Randomized, Study Investigating the Efficacy of Visual Acuity-based Versus Optical Coherence Tomography (OCT) -Based Treat and Extend Regimen Using Aflibercept in Patients With Diabetic Macular Edema
This study will evaluate the effectiveness of aflibercept (Eylea®) using two different treatment protocols in patients with vision loss from diabetic macular edema. While one group will be treated with an optical coherence tomography (OCT) guided 'treat and extend' regimen, the other group will be treated according to a visual acuity (VA) guided 'treat and extend' protocol. The patients will be randomized into two treatment arms using an automated randomization algorithm.
Read the detailed description
For the study arm receiving the VA-guided treatment regimen, the following retreatment criteria will be applied:
- if visual acuity remains stable (± 5 ETDRS letters) treatment intervals will be extended by 2 weeks as compared to the previous retreatment interval.
- if visual acuity decreases by more than 5 ETDRS letters treatment intervals will be shortened by 1 week as compared to the previous retreatment interval, whereby retreatment intervals cannot be shorter than 28 days (4 weeks). Once treatment intervals have been shortened, the patient should be seen at two consecutive visits with no diabetic retinopathy disease activity before re-extending the treatment interval.
For the study arm receiving the OCT-guided treatment regimen, the following retreatment criteria will be applied:
- if SD-OCT examinations show 1) no SRF in any area of the OCT scan present and 2) no IRF, treatment intervals will be extended by 2 weeks as compared to the previous retreatment interval.
- if SD-OCT examinations show 1) any SRF present in any area of the OCT scan and/or 2) any IRF present, treatment intervals will be shortened by 1 week as compared to the previous retreatment interval, whereby retreatment intervals cannot be shorter than 28 days (4 weeks). Once treatment intervals have been shortened, the patient should be seen at two consecutive visits with no diabetic retinopathy disease activity before re-extending the treatment interval.
- Conditions
- Diabetic Macular Edema
- Being tested
- OCT guided treatment arm, VA guided treatment arm
- Keywords
- Diabetic macular edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT guided treatment armOther
Also called aflibercept
Intravitreal injection of Aflibercept for DME OCT guided
VA guided treatment armOther
Also called aflibercept
Intravitreal injection of Aflibercept for DME VA guided
| Study group | Role | What they receive |
|---|---|---|
| OCT guided treatment arm | OCT guided aflibercept injection Receives: Other: OCT guided treatment arm | |
| VA guided treatment arm | VA guided aflibercept injection Receives: Other: VA guided treatment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcomes
Mean change in BCVA from baseline to week 104 (EOS)
Measured: 24 months
Secondary outcomes (2)
Number of visits
Number of visits per Treatment arm
Measured: 24 months
Number of injections
Number of injections per Treatment arm
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start16 Sep 2017
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: insufficient recuritment due to covid
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 Insel Gruppe AG, University Hospital BernThe 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
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Zinkernagel, MD, PhD, Study director, University of Bern, SwitzerlandMarion Munk, MD, PhD, Principal investigator, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394573
- Sponsor's protocol ID
- AVOCT
- Acronym
- AVOCT
- Status last verified
- Mar 2021
- First submitted
- 4 Jan 2016
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Study Investigating the Efficacy of Visual Acuity-based Versus Optical Coherence Tomography (OCT) -Based Treat and Extend Regimen Using Aflibercept in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03394573
- Acronym / sponsor ID
- AVOCT / AVOCT
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic macular edema
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient recuritment due to covid
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 16 Sep 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 9 Jan 2018 (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.
This study will evaluate the effectiveness of aflibercept (Eylea®) using two different treatment protocols in patients with vision loss from diabetic macular edema. While one group will be treated with an optical coherence tomography (OCT) guided 'treat and extend' regimen, the other group will be treated according to a visual acuity (VA) guided 'treat and extend' protocol. The patients will be randomized into two treatment arms using an automated randomization algorithm.
Detailed description
For the study arm receiving the VA-guided treatment regimen, the following retreatment criteria will be applied:
- if visual acuity remains stable (± 5 ETDRS letters) treatment intervals will be extended by 2 weeks as compared to the previous retreatment interval.
- if visual acuity decreases by more than 5 ETDRS letters treatment intervals will be shortened by 1 week as compared to the previous retreatment interval, whereby retreatment intervals cannot be shorter than 28 days (4 weeks). Once treatment intervals have been shortened, the patient should be seen at two consecutive visits with no diabetic retinopathy disease activity before re-extending the treatment interval.
For the study arm receiving the OCT-guided treatment regimen, the following retreatment criteria will be applied:
- if SD-OCT examinations show 1) no SRF in any area of the OCT scan present and 2) no IRF, treatment intervals will be extended by 2 weeks as compared to the previous retreatment interval.
- if SD-OCT examinations show 1) any SRF present in any area of the OCT scan and/or 2) any IRF present, treatment intervals will be shortened by 1 week as compared to the previous retreatment interval, whereby retreatment intervals cannot be shorter than 28 days (4 weeks). Once treatment intervals have been shortened, the patient should be seen at two consecutive visits with no diabetic retinopathy disease activity before re-extending the treatment interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT guided treatment arm | – | Other: OCT guided treatment armOCT guided aflibercept injection |
| VA guided treatment arm | – | Other: VA guided treatment armVA guided aflibercept injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with vision loss due to diabetic macular edema
Key inclusion criteria (9 listed)
- Informed consent as documented by signature of the patient on the informed consent form.
- Male or female, ≥ 18 years of age.
- Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines).
- No relevant change in medication for the management of diabetes within 3 months prior to randomization.
- Patients fulfilling criteria specified in the respective SmPC for aflibercept for the treatment of DME
Key exclusion criteria (19 listed)
- Inability to comply with study or follow-up procedures.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, not using or not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases.(Female participants who are surgically sterilised/ hysterectomised, or post-menopausal for longer than 2 years are not considered as being of child-bearing potential.)
- Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree.
- Stroke or myocardial infarction less than 3 months prior to the date of informed consent signature.
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 |
|---|---|---|
| OCT guided treatment armAlso: afliberceptIntravitreal injection of Aflibercept for DME OCT guided | Other | OCT guided treatment arm |
| VA guided treatment armAlso: afliberceptIntravitreal injection of Aflibercept for DME VA guided | Other | VA guided treatment arm |
Primary outcome
Functional outcomes
Time frame: 24 months
Mean change in BCVA from baseline to week 104 (EOS)
2 secondary outcomes
Number of visits
Time frame: 24 months
Number of injections
Time frame: 24 months
Results and safety
The study was stopped early (reason given: insufficient recuritment due to covid). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- 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.
Martin Zinkernagel, MD, PhD study director
University of Bern, Switzerland
Marion Munk, MD, PhD principal investigator
University of Bern, Switzerland
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 Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 9 inclusion and 19 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: stopped early, as of the sponsor's last update on 18 Mar 2021. 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 Switzerland. 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 was stopped early (reason given: insufficient recuritment due to covid). 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?
Functional outcomes (time frame: 24 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 18 Mar 2021.