Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of VA Guided Versus OCT Guided TER Using Aflibercept for Diabetic Macular Edema (AVOCT Study) (AVOCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394573
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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 a visual acuity (VA) guided 'treat and extend' protocol. The patients will be randomized into two treatment arms using an automated randomization algorithm.

Condition or disease Intervention/treatment
Diabetic Macular Edema Other: OCT guided treatment arm Other: VA guided treatment arm

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 16, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
OCT guided treatment arm
OCT guided aflibercept injection
Other: OCT guided treatment arm
Intravitreal injection of Aflibercept for DME OCT guided
Other Name: aflibercept

VA guided treatment arm
VA guided aflibercept injection
Other: VA guided treatment arm
Intravitreal injection of Aflibercept for DME VA guided
Other Name: aflibercept




Primary Outcome Measures :
  1. Functional outcomes [ Time Frame: 24 months ]
    Mean change in BCVA from baseline to week 104 (EOS)


Secondary Outcome Measures :
  1. Number of visits [ Time Frame: 24 months ]
    Number of visits per Treatment arm

  2. Number of injections [ Time Frame: 24 months ]
    Number of injections per Treatment arm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with vision loss due to diabetic macular edema
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394573


Contacts
Layout table for location contacts
Contact: Marion Munk, MD, PhD +41316329565 marion.munk@insel.ch

Locations
Layout table for location information
Switzerland
Inselspital Bern, Department of Ophthalmology Recruiting
Bern, Switzerland, 3010
Contact: Martin Zinkernagel, MD, PhD    +41316329565    martin.zinkernagel@insel.ch   
Contact: Corinne Stöckli    +41316321197    corinne.stoeckli@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Layout table for investigator information
Study Director: Martin Zinkernagel, MD, PhD University of Bern, Switzerland
Principal Investigator: Marion Munk, MD, PhD University of Bern, Switzerland
Layout table for additonal information
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03394573    
Other Study ID Numbers: AVOCT
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by University Hospital Inselspital, Berne:
Diabetic macular edema
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases