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Treat and Extend Analysis Trial With Aflibercept in Wet-AMD

Primary Purpose

Wet Age-related Macular Degeneration

Status
Active
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Aflibercept
Sponsored by
Michel Giunta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GOGIUNTA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Treat and Extend

Arm Description

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

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

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity
Change in BCVA as measured in with an ETDRS chart
Injections
Number of injections

Secondary Outcome Measures

Treatment-free intervals
Treatment frequency and duration of treatment-free intervals applied in the treat and extend dosing regimen arm
Gain of letters
Proportion of patients with gain of 5 or more, 10 or more, and 15 or more letters
Loss of letters
Proportion of patients with loss of 5 or more, 10 or more, and 15 or more letters

Full Information

First Posted
October 1, 2019
Last Updated
June 13, 2022
Sponsor
Michel Giunta
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04113538
Brief Title
Treat and Extend Analysis Trial With Aflibercept in Wet-AMD
Official Title
Exploratory and Descriptive Study Evaluating the Efficacy of Aflibercept in Bimonthly Injections Versus the ''Treat and Extend'' Dosing Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michel Giunta
Collaborators
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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
Arm Title
Treat and Extend
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Intraocular injection of 2 ml (40mg/ml)
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
Change in BCVA as measured in with an ETDRS chart
Time Frame
from baseline to week 52 (Month 12)
Title
Injections
Description
Number of injections
Time Frame
from baseline to week 52 (Month 12)
Secondary Outcome Measure Information:
Title
Treatment-free intervals
Description
Treatment frequency and duration of treatment-free intervals applied in the treat and extend dosing regimen arm
Time Frame
from baseline to week 52 (Month 12)
Title
Gain of letters
Description
Proportion of patients with gain of 5 or more, 10 or more, and 15 or more letters
Time Frame
from baseline to week 52 (Month 12)
Title
Loss of letters
Description
Proportion of patients with loss of 5 or more, 10 or more, and 15 or more letters
Time Frame
from baseline to week 52 (Month 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
GOGIUNTA
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2V4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Treat and Extend Analysis Trial With Aflibercept in Wet-AMD

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