- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394573
Comparison of VA Guided Versus OCT Guided TER Using Aflibercept for Diabetic Macular Edema (AVOCT Study) (AVOCT)
March 15, 2021 updated by: University Hospital Inselspital, Berne
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bern, Switzerland, 3010
- Inselspital Bern, Department of Ophthalmology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with vision loss due to diabetic macular edema
Description
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
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
Inclusion criteria:
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
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
Exclusion criteria:
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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
OCT guided treatment arm
OCT guided aflibercept injection
|
Intravitreal injection of Aflibercept for DME OCT guided
Other Names:
|
VA guided treatment arm
VA guided aflibercept injection
|
Intravitreal injection of Aflibercept for DME VA guided
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional outcomes
Time Frame: 24 months
|
Mean change in BCVA from baseline to week 104 (EOS)
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of visits
Time Frame: 24 months
|
Number of visits per Treatment arm
|
24 months
|
Number of injections
Time Frame: 24 months
|
Number of injections per Treatment arm
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Martin Zinkernagel, MD, PhD, University of Bern, Switzerland
- Principal Investigator: Marion Munk, MD, PhD, University of Bern, Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2017
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
February 1, 2021
Study Registration Dates
First Submitted
January 4, 2016
First Submitted That Met QC Criteria
January 8, 2018
First Posted (Actual)
January 9, 2018
Study Record Updates
Last Update Posted (Actual)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 15, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVOCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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