Treat and Extend Analysis Trial With Aflibercept in Wet-AMD

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Wet Age-related Macular Degeneration
• Intervention / Treatment: Drug: Aflibercept

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1G 2V4
      • GOGIUNTA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; 2 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	Drug: Aflibercept; Intraocular injection of 2 ml (40mg/ml); Other Names: Eylea
Experimental: Treat and Extend; 2 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	Drug: Aflibercept; Intraocular injection of 2 ml (40mg/ml); Other Names: Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity	Change in BCVA as measured in with an ETDRS chart	from baseline to week 52 (Month 12)
Injections	Number of injections	from baseline to week 52 (Month 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-free intervals	Treatment frequency and duration of treatment-free intervals applied in the treat and extend dosing regimen arm	from baseline to week 52 (Month 12)
Gain of letters	Proportion of patients with gain of 5 or more, 10 or more, and 15 or more letters	from baseline to week 52 (Month 12)
Loss of letters	Proportion of patients with loss of 5 or more, 10 or more, and 15 or more letters	from baseline to week 52 (Month 12)

Collaborators and Investigators

• Sponsor: Michel Giunta
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: GOGIUNTA

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