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

Neovascular Age-related Macular Degeneration Clinical Trial

— FAN  

Official title:

Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration: a Monocenter, Randomized, Double-masked Comparator-controlled Study (FAN)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05941715
• Other study ID #: 35-200 ex 22/23
• Secondary ID: 2023-000037-32
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 4, 2023
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: February 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Aflibercept 40 MG/ML
treat-and-extend
• Faricimab 120 MG/ML
treat-and-extend

Locations

Country	Name	City	State
Austria	Department of Ophthalmolgy, Medical University Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean change in ETDRS letter score	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).	from baseline to an averaged EDTRS letter score between 24-32 weeks and between 48-56 weeks
Other	Mean averaged ETDRS letter score	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).	between 24-32 weeks and between 48-56 weeks
Other	Proportion of eyes gaining = 5 EDTRS letters		from baseline to an averaged ETDRS letter score between 24-32 weeks and between 48-56 weeks
Other	Proportion of eyes loosing =5 EDTRS letters		from baseline to an averaged ETDRS letter score between 24-32 weeks and between 48-56 weeks
Other	Mean change in low-luminance Best Corrected Visual Acuity (BCVA)		from baseline to last visit at or before 32 weeks and last visit at or before 56 weeks
Other	Mean change in central subfield thickness (CST)	CST is measured using optical coherence tomography (OCT).	from baseline to an averaged CST between 24-32 weeks and between 48-56 weeks
Other	Proportion of eyes with no intraretinal fluid	Intraretinal fluid is assessed via optical coherence tomography (OCT).	at baseline, last visit at or before 32 weeks and at or before 56 weeks
Other	Proportion of eyes with no subretinal fluid	Subretinal fluid is assessed via optical coherence tomography (OCT).	at baseline, last visit at or before 32 weeks and at or before 56 weeks
Other	Proportion of eyes with no intra- and subretinal fluid	Intra- and subretinal fluid is assessed via optical coherence tomography (OCT).	at baseline, last visit at or before 32 weeks and at or before 56 weeks
Other	Retinal nerve fiber layer (RNFL) thickness	RNFL thickness is assessed via optical coherence tomography (OCT).	at baseline, last visit at or before 32 weeks and last visit at or before 56 weeks
Other	Concentration of plasma vascular endothelial growth factor A (VEGF-A) and Angiopoietin-2 (Ang-2)	Plasma VEGF-A and Ang-2 is determined using a validated enzyme-linked immunosorbent assay (ELISA).	at baseline, one week after baseline, four weeks after baseline and last visit at or before 32 weeks
Other	Patient-reported vision-related functioning and quality of life	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).	at screening, last visit at or before 32 weeks and last visit at or before 56 weeks
Other	Presence of safety outcomes	Rates of adverse events (AE's) and serious adverse events (SAE's) are given.	from baseline through to week 56
Primary	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.	at 32 weeks
Secondary	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.	at 32 weeks and 56 weeks
Secondary	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.	at 32 weeks and 56 weeks
Secondary	Number of injections received		during 32 weeks and 1 year
Secondary	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.	at 32 weeks and 56 weeks