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

NCT03394573 | Terminated

• 1 other identifier: AVOCT
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edema

Outcome Measures

Primary Outcomes (1)

• Functional outcomes

  Mean change in BCVA from baseline to week 104 (EOS)

  24 months

Secondary Outcomes (2)

• Number of visits

  24 months

• Number of injections

  24 months

Study Arms (2)

OCT guided treatment arm

OCT guided aflibercept injection

Other: OCT guided treatment arm

VA guided treatment arm

VA guided aflibercept injection

Other: VA guided treatment arm

Interventions

OCT guided treatment arm OTHER

Intravitreal injection of Aflibercept for DME OCT guided

Also known as: aflibercept

OCT guided treatment arm

VA guided treatment arm OTHER

Intravitreal injection of Aflibercept for DME VA guided

Also known as: aflibercept

VA guided treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with vision loss due to diabetic macular edema

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern, Department of Ophthalmology

Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Martin Zinkernagel, MD, PhD

  University of Bern, Switzerland

  STUDY DIRECTOR

• Marion Munk, MD, PhD

  University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 9, 2018
• Study Start: September 16, 2017
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)