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Wet Age-related Macular DegenerationPhase 3NCT04113538

Treat and Extend Analysis Trial With Aflibercept in Wet-AMD

A Phase 3 study testing Aflibercept in people with Wet Age-related Macular Degeneration, run by Michel Giunta at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a randomized, prospective, exploratory, descriptive, open label, parallel group, post-authorization study designed to describe and evaluate two aflibercept treatment regimens aimed at achieving and maintaining a maximum visual function benefit (i.e., BCVA stability). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
24 Jul 2019to May 2023
Phase
Phase 3
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient who are able to give written informed consent
  • Patients 50 years of age or older
  • Patients with a diagnosis of treatmenttreatment-naive CNV secondary to AMD in the study eye, for which aflibercept treatment hashas been prescribed by the treating physician. This includes patients with lesion(s) with less than 50% hemorrhage, less that 50% fibrosis, and/or serious pigment epithelial detachment (PED)
  • Patients with best corrected visual acuity score in the study eye between 78 and 19 letters inclusively, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/400 at screening)
  • Females of childbearing potential must, in the opinion of the Investigator, be using a medically effective method of contraception to prevent pregnancy and agree to use an acceptable method of contraception for the duration of their participation in this study. Effective contraception should be used by subjects during the study and for three months after treatment. Effective methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception.

Who cannot join

  • Patients with a structural foveal damage - advanced sub retinal fibrosis or significant geographic atrophy involving the foveal center (lack of morphological reserve) in the study eye
  • Patients with confounding severe ocular disease in the study eye (such as uncontrolled glaucoma, diabetic retinopathy likely to be visually significant within 2 years, cataract presumably requiring surgery within 2 years) -vitreous or pre-retinal haemorrhage obscuring the central macula, or presence of rhegmatogenous retinal detachment
  • Patients with clinical suspicion of polypoidal choroidal vasculopathy
  • Patients with active or suspected ocular per ocular infections in either eye
  • Patients with active intraocular inflammation in either eye
  • Patients with a known sensitivity to Aflibercept or any component of its formulation
Show all 13Show fewer
  • Patients physically unable to tolerate intravenous fluorescein angiography
  • Pregnant or breastfeeding female patients
  • Any patient with recent history of new onset cardiac disease or thromboembolic event (within 12 months of Baseline visit)
  • Patients having received systemic treatment with any other anti-VEGF therapy 60 days prior to enrollment
  • Patients having had any prior treatment in the study eye (Avastin, Lucentis, Visudyne, Ozurdex, external radiation therapy, transpupillary thermotherapy, or any intravitreal injection)
  • Concurrent participation in a clinical trial or within 30 days prior to enrollment
  • Patients with any other condition which, in the opinion of the principal investigator, would require treatment that would significantly impact the treatment assessments during the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • GOGIUNTA

    Sherbrooke, Quebec, J1G 2V4

Other trials in Canada

About this study

Official title: Exploratory and Descriptive Study Evaluating the Efficacy of Aflibercept in Bimonthly Injections Versus the ''Treat and Extend'' Dosing Regimen

This study is a randomized, prospective, exploratory, descriptive, open label, parallel group, post-authorization study designed to describe and evaluate two aflibercept treatment regimens aimed at achieving and maintaining a maximum visual function benefit (i.e., BCVA stability). The goal of the study is to compare two strategies for dosing regimen with aflibercept in wet AMD: the standard regimen (one injection every 8 weeks after 3 monthly loading doses in the treatment of wet age-related macular degeneration) versus the treat and extend protocol (details outlined below in the "Study Design" section) aiming at achieving and maintaining maximum visual acuity benefit while minimizing the number of injections. Patients will be randomized at week 8 (Month 2) in a proportion of 1:2 (Standard treatment : treat and extend treatment). We aim to demonstrate that the Treat and Extend regimen is equivalent or better to the standard fixed interval regimen in terms of change in patients' visual acuity after a year of treatment and that patients in the Treat and Extend arm will receive fewer injections and fewer visits, than their counterparts in the standard regimen arm. The results could be used to generate a base for future controlled-randomized clinical trials on the timing of treatment administration for patients with wAMD.

Being tested
Aflibercept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfliberceptDrug

    Also called Eylea

    Intraocular injection of 2 ml (40mg/ml)

Study groups in NCT04113538
Study groupRoleWhat they receive
StandardActive comparator2 ml (40 mg/ml) of Eylea solution : loading dose of 3 intravitreal injections every 4 weeks for the first 3 months followed by an injection every 8 weeks until the end of the study
Receives: Drug: Aflibercept
Treat and ExtendExperimental2 ml (40 mg/ml) of Eylea solution : loading dose of 3 intravitreal injections every 4 weeks for the first 3 months followed and, until the end of the study, retreatment interval based on disease stability
Receives: Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Corrected Visual Acuity

    Change in BCVA as measured in with an ETDRS chart

    Measured: from baseline to week 52 (Month 12)

  2. Injections

    Number of injections

    Measured: from baseline to week 52 (Month 12)

Secondary outcomes (3)

  1. Treatment-free intervals

    Treatment frequency and duration of treatment-free intervals applied in the treat and extend dosing regimen arm

    Measured: from baseline to week 52 (Month 12)

  2. Gain of letters

    Proportion of patients with gain of 5 or more, 10 or more, and 15 or more letters

    Measured: from baseline to week 52 (Month 12)

  3. Loss of letters

    Proportion of patients with loss of 5 or more, 10 or more, and 15 or more letters

    Measured: from baseline to week 52 (Month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2019
  2. Study start24 Jul 2019
  3. Primary completionJan 2023 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04113538
Sponsor's protocol ID
GOGIUNTA
Status last verified
Jun 2022
First submitted
1 Oct 2019
Last updated
14 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aflibercept in people with Wet Age-related Macular Degeneration, run by Michel Giunta at 1 site in Canada.

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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Best Corrected Visual Acuity (time frame: from baseline to week 52 (Month 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04113538.

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 14 Jun 2022.

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