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Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration (FAN)

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Recruiting
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Aflibercept 40 MG/ML
Faricimab 120 MG/ML
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring aflibercept, faricimab, treat and extend, nAMD, AMD, neovascular age-related macular degeneration

Eligibility Criteria

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

Ocular inclusion criteria: MNV due to AMD (nAMD) BVCA between and including 19 and 75 letters (Snellen equivalent approximately 20/400 to 20/32) ≥ 7 previous intravitreal injections with anti-VEGF the last ≥ 4 consecutive intravitreal injections with aflibercept the last aflibercept injections within the last 35 days interval between the last 2 aflibercept injections ≤ 35 days Ocular exclusion criteria: MNV due to other causes than nAMD polypoidal choroidal neovascularization retinal pigment epithelial rip/tear subretinal hemorrhage of > 50% of the lesion, involving the fovea any macular pathology other than AMD causing structural changes of the macula and thereby affecting vision any active intra-/periocular infection/inflammation of the study eye uncontrolled glaucoma under medication (IOP >25mmHg) cataract surgery of the study eye within the last 3 months previous intraocular surgery of the study eye other than cataract surgery or intravitreal injections with anti-VEGF (e.g. vitrectomy, corneal transplant, glaucoma surgery) any previous laser therapy of the study eye other than Yag (yttrium aluminium garnet) laser capsulotomy (e.g. panretinal photocoagulation, verteporfin photodynamic therapy) refractive error of more than -6 diopters myopia vitreous hemorrhage retinal detachment General exclusion criteria use of long-term systemic corticosteroids within the last 3 months uncontrolled blood pressure (either/both systolic blood pressure >180mmHg, diastolic blood pressure >100mmHg) pregnancy (pre-menopausal women MUST take a pregnancy test at time of initiation) breast-feeding myocardial infarction or stroke within the last six months concomitant participation in another clinical study with investigational medicinal products a known allergy or hypersensitivity towards eye drops needed for the examinations planned during the study, and/or the intravitreal procedure. a known allergy or hypersensitivity against fluorescein / indocyanine green used during angiography a known allergy or hypersensitivity towards any of the components of the study drug

Sites / Locations

  • Department of Ophthalmolgy, Medical University GrazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

group A: aflibercept first (part 1), switch to faricimab (part 2)

group B: faricimab monotherapy

Arm Description

Aflibercept 2.0mg/0.05ml intravitreal will be administered from baseline through to the first visit at or after 32 weeks in a treat-and-extend regime. At the first visit at or after 32 weeks, faricimab 6.0mg/0.05ml intravitreal will be administered in a treat-and-extend regime through to the last visit before 56 weeks.

Faricimab 6.0mg/0.05ml intravitreal will be administered from baseline through to the last visit before 56 weeks in a treat-and-extend regime.

Outcomes

Primary Outcome Measures

Proportion of eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate)
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.

Secondary Outcome Measures

Proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 weeks and (≥ 12weeks)
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Maximum extended treatment interval without retinal (intra- and subretinal) fluid
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Number of injections received
Proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval)
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.

Full Information

First Posted
June 19, 2023
Last Updated
July 20, 2023
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT05941715
Brief Title
Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration
Acronym
FAN
Official Title
Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration: a Monocenter, Randomized, Double-masked Comparator-controlled Study (FAN)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study purpose: To evaluate if previously high-frequent (3-5 weekly) aflibercept treated neovascular age-related macular degeneration (nAMD) can be extended in their treatment interval when switched to faricimab. Primary objective: To assess the efficacy of faricimab compared to aflibercept in terms of durability at 32 weeks by extending treatment interval in previous high-frequent aflibercept treated nAMD.
Detailed Description
There is a subgroup of nAMD patient requiring monthly interventions, when applying as needed and treat-and-extend treatment strategies. A burden for both patient/caregivers and health care systems. More durable treatment options are needed to increase the quality of life for these nAMD patients, as well as to make human resources available for the growing elderly AMD population requiring treatment. The FAN study is a randomized, double-masked, 2-arm (comparator-controlled), phase-IV, monocenter study with a primary endpoint at 32 weeks. The study is conducted into 2 parts. Patients will receive either aflibercept or faricimab via treat-and-extend principle until the primary endpoint (part 1). As mentioned, the main objective is to assess the durability of both drugs in this particular subgroup of nAMD patients. In part 2 of the study, starting at or after 32 weeks, all patients will receive faricimab via treat-and-extend until the end of the study (56 weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
aflibercept, faricimab, treat and extend, nAMD, AMD, neovascular age-related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A: aflibercept first (part 1), switch to faricimab (part 2)
Arm Type
Active Comparator
Arm Description
Aflibercept 2.0mg/0.05ml intravitreal will be administered from baseline through to the first visit at or after 32 weeks in a treat-and-extend regime. At the first visit at or after 32 weeks, faricimab 6.0mg/0.05ml intravitreal will be administered in a treat-and-extend regime through to the last visit before 56 weeks.
Arm Title
group B: faricimab monotherapy
Arm Type
Experimental
Arm Description
Faricimab 6.0mg/0.05ml intravitreal will be administered from baseline through to the last visit before 56 weeks in a treat-and-extend regime.
Intervention Type
Drug
Intervention Name(s)
Aflibercept 40 MG/ML
Other Intervention Name(s)
Eylea®
Intervention Description
treat-and-extend
Intervention Type
Drug
Intervention Name(s)
Faricimab 120 MG/ML
Other Intervention Name(s)
Vabysmo®
Intervention Description
treat-and-extend
Primary Outcome Measure Information:
Title
Proportion of eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate)
Description
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Time Frame
at 32 weeks
Secondary Outcome Measure Information:
Title
Proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 weeks and (≥ 12weeks)
Description
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Time Frame
at 32 weeks and 56 weeks
Title
Maximum extended treatment interval without retinal (intra- and subretinal) fluid
Description
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Time Frame
at 32 weeks and 56 weeks
Title
Number of injections received
Time Frame
during 32 weeks and 1 year
Title
Proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval)
Description
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Time Frame
at 32 weeks and 56 weeks
Other Pre-specified Outcome Measures:
Title
Mean change in ETDRS letter score
Description
Best Corrected Visual Acuity (BCVA) is measured via Early Treatment Diabetic Retinopathy Severity (ETDRS) charts. The ETDRS letter score ranges from 0 to 100 (best score).
Time Frame
from baseline to an averaged EDTRS letter score between 24-32 weeks and between 48-56 weeks
Title
Mean averaged ETDRS letter score
Description
Best Corrected Visual Acuity (BCVA) is measured via Early Treatment Diabetic Retinopathy Severity (ETDRS) charts. The ETDRS letter score ranges from 0 to 100 (best score).
Time Frame
between 24-32 weeks and between 48-56 weeks
Title
Proportion of eyes gaining ≥ 5 EDTRS letters
Time Frame
from baseline to an averaged ETDRS letter score between 24-32 weeks and between 48-56 weeks
Title
Proportion of eyes loosing ≥5 EDTRS letters
Time Frame
from baseline to an averaged ETDRS letter score between 24-32 weeks and between 48-56 weeks
Title
Mean change in low-luminance Best Corrected Visual Acuity (BCVA)
Time Frame
from baseline to last visit at or before 32 weeks and last visit at or before 56 weeks
Title
Mean change in central subfield thickness (CST)
Description
CST is measured using optical coherence tomography (OCT).
Time Frame
from baseline to an averaged CST between 24-32 weeks and between 48-56 weeks
Title
Proportion of eyes with no intraretinal fluid
Description
Intraretinal fluid is assessed via optical coherence tomography (OCT).
Time Frame
at baseline, last visit at or before 32 weeks and at or before 56 weeks
Title
Proportion of eyes with no subretinal fluid
Description
Subretinal fluid is assessed via optical coherence tomography (OCT).
Time Frame
at baseline, last visit at or before 32 weeks and at or before 56 weeks
Title
Proportion of eyes with no intra- and subretinal fluid
Description
Intra- and subretinal fluid is assessed via optical coherence tomography (OCT).
Time Frame
at baseline, last visit at or before 32 weeks and at or before 56 weeks
Title
Retinal nerve fiber layer (RNFL) thickness
Description
RNFL thickness is assessed via optical coherence tomography (OCT).
Time Frame
at baseline, last visit at or before 32 weeks and last visit at or before 56 weeks
Title
Concentration of plasma vascular endothelial growth factor A (VEGF-A) and Angiopoietin-2 (Ang-2)
Description
Plasma VEGF-A and Ang-2 is determined using a validated enzyme-linked immunosorbent assay (ELISA).
Time Frame
at baseline, one week after baseline, four weeks after baseline and last visit at or before 32 weeks
Title
Patient-reported vision-related functioning and quality of life
Description
Patient-reported vision-related functioning and quality of life is assessed via National Eye Institute Visual Function Questionnaire (VFQ-25). VFQ-25 score ranges from 0 to 100 (highest score).
Time Frame
at screening, last visit at or before 32 weeks and last visit at or before 56 weeks
Title
Presence of safety outcomes
Description
Rates of adverse events (AE's) and serious adverse events (SAE's) are given.
Time Frame
from baseline through to week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Ocular inclusion criteria: MNV due to AMD (nAMD) BVCA between and including 19 and 75 letters (Snellen equivalent approximately 20/400 to 20/32) ≥ 7 previous intravitreal injections with anti-VEGF the last ≥ 4 consecutive intravitreal injections with aflibercept the last aflibercept injections within the last 35 days interval between the last 2 aflibercept injections ≤ 35 days Ocular exclusion criteria: MNV due to other causes than nAMD polypoidal choroidal neovascularization retinal pigment epithelial rip/tear subretinal hemorrhage of > 50% of the lesion, involving the fovea any macular pathology other than AMD causing structural changes of the macula and thereby affecting vision any active intra-/periocular infection/inflammation of the study eye uncontrolled glaucoma under medication (IOP >25mmHg) cataract surgery of the study eye within the last 3 months previous intraocular surgery of the study eye other than cataract surgery or intravitreal injections with anti-VEGF (e.g. vitrectomy, corneal transplant, glaucoma surgery) any previous laser therapy of the study eye other than Yag (yttrium aluminium garnet) laser capsulotomy (e.g. panretinal photocoagulation, verteporfin photodynamic therapy) refractive error of more than -6 diopters myopia vitreous hemorrhage retinal detachment General exclusion criteria use of long-term systemic corticosteroids within the last 3 months uncontrolled blood pressure (either/both systolic blood pressure >180mmHg, diastolic blood pressure >100mmHg) pregnancy (pre-menopausal women MUST take a pregnancy test at time of initiation) breast-feeding myocardial infarction or stroke within the last six months concomitant participation in another clinical study with investigational medicinal products a known allergy or hypersensitivity towards eye drops needed for the examinations planned during the study, and/or the intravitreal procedure. a known allergy or hypersensitivity against fluorescein / indocyanine green used during angiography a known allergy or hypersensitivity towards any of the components of the study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monja Michelitsch, MD
Phone
0043(0)31638513817
Email
monja.michelitsch@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Wedrich, MD
Organizational Affiliation
Department of Ophthalmology, Medical University Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmolgy, Medical University Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Wedrich
Phone
0043(0)31638513817
Email
andreas.wedrich@medunigraz.at

12. IPD Sharing Statement

Learn more about this trial

Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration

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