Wet Age-related Macular DegenerationPhase 4NCT06875245
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals
A Phase 4 study testing Faricimab Injection in people with Wet Age-related Macular Degeneration, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial summary
This is a prospective, randomized study that compares 8-week and 12-week follow-up intervals after the 4 monthly injections in the loading phase. Patients with active CNV confirmed on optical coherence tomography (OCT) and OCT angiography (OCTA) will be randomized into two groups and followed for 44 to 56 weeks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- Faricimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 31 Mar 2023to Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Active treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA
- BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye
- presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT
- patient capable of signing the informed consent
Who cannot join
- Myocardial Infarction or Stroke in the last 3 months
- Previous or current conditions of the study eye:
- subretinal haemorrhage comprising more than 25% of the lesion in the study eye
- scar or fibrosis comprising more than 50% of the lesion in the study eye
- presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
- total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
Show all 15Show fewer
- uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
- idiopathic or autoimmune uveitis in the study eye
- other pathologies in the macula of the study eye unrelated to AMD which can be expected to influence the BCVA (e.g. macular hole, epiretinal membrane, etc.)
- significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or OCT examination
- diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye
- extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit
- any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
- allergy or hypersensitivity to any component contained in the study drug
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Faculty hospital Kralovske Vinohrady
Prague, 100 34
Martin Pencak, M.D., +420 267 16 3637, pencak@volny.cz
About this study
Official title: Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals Following 4 Loading Doses - Prospective Randomised Study
This is a prospective, randomized study that compares 8-week and 12-week follow-up intervals after the 4 monthly injections in the loading phase. Patients with active CNV confirmed on optical coherence tomography (OCT) and OCT angiography (OCTA) will be randomized into two groups and followed for 44 to 56 weeks.
Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks, followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.
Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval. Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups.
Read the detailed description
Wet age-related macular degeneration (wet AMD) is a progressive eye disease that affects the macula, the part of the retina responsible for sharp central vision. The treatment of wet AMD choroidal neovascularization (CNV) with intravitreal antiVEGF drugs is highly effective. In our study, we aim to compare the efficacy of standard (8 weeks) versus extended follow-up dosing interval (12 weeks) following 4 monthly loading injections of the new combined-mechanism medication, faricimab (6 mg intravitreal dose), which targets both VEGF-A and Ang-2 receptors, in the treatment of wet AMD. We will include all types of CNVs in our study, including Type 1 (occult), Type 2 (classic), Type 3 CNV (Retinal Angiomatous Proliferation = RAP) and mixed CNV. This is a prospective, randomised, comparative study comparing the best corrected visual acuity (BCVA) and central retinal thickness (CRT) on optical coherence tomography (OCT) in the 20th, 24th week of the study between both groups. The total number of injections between both groups will be also compared at the final visit, which will take place between the 44th and 56th week of the study based on the dosing interval.
Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks (Week 20 Visit), followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.
Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval (Week 24 Visit). Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups.
Visit plan:
Screening visit - 14 to 0 day prior to baseline. Informed consent will be signed prior to any other study procedures. Ocular and medical history will be written down. BCVA of both eyes will be tested on ETDRS charts. Non-contact intraocular pressure (IOP) will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. The OCT scan of both eyes will be performed, and OCTA will be performed in the treatment naïve eyes. Based on the examination results, patients' eligibility for the study will be assessed.
Baseline - day 1 - BCVA of both eyes will be tested on ETDRS charts. Non-contact IOP will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed with artificial mydriasis. OCT of both eyes will be performed. Based on the examination results, patients' eligibility for the study will be assessed. Eligible patients will be randomised, and study medication will be given.
Week 4, Week 8, and Week 12 - adverse events connected to study drugs or study procedures will be assessed and study medication will be given.
Extension Visit Week 20 (group 1) or Week 24 (group 2) - After an initial loading phase of four monthly doses, the two groups differ in the length of the extended dosing intervals. Adverse events connected to study drugs or study procedures will be assessed. BCVA of both eyes will be tested on ETDRS charts. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. OCT of both eyes will be performed. Study medication will be given.
Next treatment visit will be scheduled based on the disease activity on the OCT, the ocular examination findings and the BCVA in treat-and-extend regimen with minimal interval of 8 weeks and maximal interval of 16 weeks. The therapeutic interval in both groups may be extended or shortened in up to 4-week increments based on the patient's visual acuity and disease activity, as assessed by OCT evaluating the presence or absence of subretinal or intraretinal fluid or pigment epithelial detachment (PED) and on the presence of other signs of disease activity on the fundus examination (haemorrhage, hard exudates, etc.). It is up to the investigator to make the final decision on the treatment interval.
Follow-up Visits Week 20 to Week 56 - Treat-and-extend regimen. Adverse events connected to study drugs or study procedures will be assessed. BCVA of both eyes will be tested on ETDRS charts. Non-contact IOP will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. OCT of both eyes will be performed. Study medication will be given. Next treatment visit will be scheduled based on the disease activity as described above (treat-and-extend regimen with possible up to 4-week adjustments).
End of Study Visit Week 44-56 - Adverse events assessment. BCVA of both eyes will be tested on ETDRS charts. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. OCT of both eyes will be performed. OCTA of the study eye (SE) will be performed.
Study procedures:
OCT - performed on Spectralis OCT (Heidelberg Engineering GmbH, Heidelberg, Germany). CRT will be assessed from automatic retinal thickness analysis in 9 ETDRS subfields including the central subfield. 49 horizontal scans in the angle of 20x20° 123 um apart in High resolution mode with noise reduction set to ART=4 will be performed.
OCTA - performed on Spectralis OCT (Heidelberg Engineering GmbH, Heidelberg, Germany). 512 horizontal scans in the angle of 20x20° 11 um apart in High-speed mode with noise reduction set to ART=5 will be performed.
Disease activity assessment:
Based on the decision of the investigator. Shortening of the treatment interval is recommended when the BCVA decrease of more than 5 ETDRS letters is observed, in case of intra- or subretinal fluid or PED reappearance or increase on the OCT or when new haemorrhage or hard exudates are observed in the macula. Extension of the treatment interval is recommended in the absence of intra- and subretinal fluid and PED on the OCT with better or stable BCVA, or in case the BCVA and OCT findings are stable after 3 injections in the shortest possible interval.
Rescue therapy: Aflibercept may be given as a rescue therapy in case of patients with study drug related sight threatening adverse events or with worsening of BCVA and OCT findings even on the shortest treatment interval when resistance to study drug is suspected. Switch to rescue therapy must be consulted with and approved by principal investigator.
Eligibility
Inclusion criteria:
Active treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA
BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye
presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT
patient capable of signing the informed consent
Exclusion Criteria:
Myocardial Infarction or Stroke in the last 3 months
Previous or current conditions of the study eye:
- subretinal haemorrhage comprising more than 25% of the lesion in the study eye
- scar or fibrosis comprising more than 50% of the lesion in the study eye
- presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
- total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
- uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
- idiopathic or autoimmune uveitis in the study eye
- other pathologies in the macula of the study eye unrelated to AMD which can be expected to influence the BCVA (e.g. macular hole, epiretinal membrane, etc.)
- significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or OCT examination
- diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye
- extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit
- any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
- allergy or hypersensitivity to any component contained in the study drug
- pregnant or breastfeeding women
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- Faricimab Injection
- Keywords
- retina, amd, faricimab, macula
- Medical subject headings
- Glycogen Storage Disease Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faricimab InjectionDrug
Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1, 8-Week | Experimental | Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks (Week 20 Visit), followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks. Receives: Drug: Faricimab Injection |
| Group 2, 12-Week | Experimental | Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval (Week 24 Visit). Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. Receives: Drug: Faricimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CRT
Change in central subfield thickness (CST) over time as measured by SD-OCT
Measured: from baseline up to 56 weeks
Patients with intraretinal or subretinal fluid or serous pigment epithelium detachment after loading
Number of patients with subretinal, intraretinal fluid or pigment epithelium detachment (PED) at week 20 (Group 1) or week 24 (Group 2)
Measured: From baseline to week 20 (Group 1) or week 24 (Group 2)
Secondary outcomes (4)
Change from baseline in BCVA
Change in best-corrected visual acuity over time as measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters
Measured: From baseline up to 56 weeks
Presence of fluid
Proportion of patients with presence of central retina intraretinal fluid, subretinal fluid, and both at final study visit
Measured: From baseline up to 56 weeks
Number of injections
Number of faricimab injections received during the study duration.
Measured: From baseline up to 56 weeks
Treatment interval
The proportion of patients on a every 4 weeks (Q4w) to every 8 weeks (Q8W), Q8W to every 12 weeks (Q12W), and Q12W to every 16 weeks (Q16W) treatment interval during the study
Measured: From baseline up to 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start31 Mar 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Martin Pencak, Faculty Hospital Kralovske Vinohrady
- Investigators
- Martin Pencak, MD, Principal investigator, +420 267 16 3637
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875245
- Sponsor's protocol ID
- VAB 8/12 V1.0
- Status last verified
- Mar 2025
- First submitted
- 30 Oct 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals Following 4 Loading Doses - Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT06875245
- Acronym / sponsor ID
- VAB 8/12 V1.0
- Conditions
- Wet Age-related Macular Degeneration
- Keywords
- retina, amd, faricimab, macula
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized study that compares 8-week and 12-week follow-up intervals after the 4 monthly injections in the loading phase. Patients with active CNV confirmed on optical coherence tomography (OCT) and OCT angiography (OCTA) will be randomized into two groups and followed for 44 to 56 weeks.
Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks, followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.
Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval. Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups.
Detailed description
Wet age-related macular degeneration (wet AMD) is a progressive eye disease that affects the macula, the part of the retina responsible for sharp central vision. The treatment of wet AMD choroidal neovascularization (CNV) with intravitreal antiVEGF drugs is highly effective. In our study, we aim to compare the efficacy of standard (8 weeks) versus extended follow-up dosing interval (12 weeks) following 4 monthly loading injections of the new combined-mechanism medication, faricimab (6 mg intravitreal dose), which targets both VEGF-A and Ang-2 receptors, in the treatment of wet AMD. We will include all types of CNVs in our study, including Type 1 (occult), Type 2 (classic), Type 3 CNV (Retinal Angiomatous Proliferation = RAP) and mixed CNV. This is a prospective, randomised, comparative study comparing the best corrected visual acuity (BCVA) and central retinal thickness (CRT) on optical coherence tomography (OCT) in the 20th, 24th week of the study between both groups. The total number of injections between both groups will be also compared at the final visit, which will take place between the 44th and 56th week of the study based on the dosing interval.
Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks (Week 20 Visit), followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.
Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval (Week 24 Visit). Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups.
Visit plan:
Screening visit - 14 to 0 day prior to baseline. Informed consent will be signed prior to any other study procedures. Ocular and medical history will be written down. BCVA of both eyes will be tested on ETDRS charts. Non-contact intraocular pressure (IOP) will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. The OCT scan of both eyes will be performed, and OCTA will be performed in the treatment naïve eyes. Based on the examination results, patients' eligibility for the study will be assessed.
Baseline - day 1 - BCVA of both eyes will be tested on ETDRS charts. Non-contact IOP will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed with artificial mydriasis. OCT of both eyes will be performed. Based on the examination results, patients' eligibility for the study will be assessed. Eligible patients will be randomised, and study medication will be given.
Week 4, Week 8, and Week 12 - adverse events connected to study drugs or study procedures will be assessed and study medication will be given.
Extension Visit Week 20 (group 1) or Week 24 (group 2) - After an initial loading phase of four monthly doses, the two groups differ in the length of the extended dosing intervals. Adverse events connected to study drugs or study procedures will be assessed. BCVA of both eyes will be tested on ETDRS charts. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. OCT of both eyes will be performed. Study medication will be given.
Next treatment visit will be scheduled based on the disease activity on the OCT, the ocular examination findings and the BCVA in treat-and-extend regimen with minimal interval of 8 weeks and maximal interval of 16 weeks. The therapeutic interval in both groups may be extended or shortened in up to 4-week increments based on the patient's visual acuity and disease activity, as assessed by OCT evaluating the presence or absence of subretinal or intraretinal fluid or pigment epithelial detachment (PED) and on the presence of other signs of disease activity on the fundus examination (haemorrhage, hard exudates, etc.). It is up to the investigator to make the final decision on the treatment interval.
Follow-up Visits Week 20 to Week 56 - Treat-and-extend regimen. Adverse events connected to study drugs or study procedures will be assessed. BCVA of both eyes will be tested on ETDRS charts. Non-contact IOP will be measured. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. OCT of both eyes will be performed. Study medication will be given. Next treatment visit will be scheduled based on the disease activity as described above (treat-and-extend regimen with possible up to 4-week adjustments).
End of Study Visit Week 44-56 - Adverse events assessment. BCVA of both eyes will be tested on ETDRS charts. Slit lamp anterior segment examination and fundus biomicroscopy of both eyes will be performed in artificial mydriasis. OCT of both eyes will be performed. OCTA of the study eye (SE) will be performed.
Study procedures:
OCT - performed on Spectralis OCT (Heidelberg Engineering GmbH, Heidelberg, Germany). CRT will be assessed from automatic retinal thickness analysis in 9 ETDRS subfields including the central subfield. 49 horizontal scans in the angle of 20x20° 123 um apart in High resolution mode with noise reduction set to ART=4 will be performed.
OCTA - performed on Spectralis OCT (Heidelberg Engineering GmbH, Heidelberg, Germany). 512 horizontal scans in the angle of 20x20° 11 um apart in High-speed mode with noise reduction set to ART=5 will be performed.
Disease activity assessment:
Based on the decision of the investigator. Shortening of the treatment interval is recommended when the BCVA decrease of more than 5 ETDRS letters is observed, in case of intra- or subretinal fluid or PED reappearance or increase on the OCT or when new haemorrhage or hard exudates are observed in the macula. Extension of the treatment interval is recommended in the absence of intra- and subretinal fluid and PED on the OCT with better or stable BCVA, or in case the BCVA and OCT findings are stable after 3 injections in the shortest possible interval.
Rescue therapy: Aflibercept may be given as a rescue therapy in case of patients with study drug related sight threatening adverse events or with worsening of BCVA and OCT findings even on the shortest treatment interval when resistance to study drug is suspected. Switch to rescue therapy must be consulted with and approved by principal investigator.
Eligibility
Inclusion criteria:
Active treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA
BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye
presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT
patient capable of signing the informed consent
Exclusion Criteria:
Myocardial Infarction or Stroke in the last 3 months
Previous or current conditions of the study eye:
- subretinal haemorrhage comprising more than 25% of the lesion in the study eye
- scar or fibrosis comprising more than 50% of the lesion in the study eye
- presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
- total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
- uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
- idiopathic or autoimmune uveitis in the study eye
- other pathologies in the macula of the study eye unrelated to AMD which can be expected to influence the BCVA (e.g. macular hole, epiretinal membrane, etc.)
- significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or OCT examination
- diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye
- extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit
- any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
- allergy or hypersensitivity to any component contained in the study drug
- pregnant or breastfeeding women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, 8-Week | Experimental | Drug: Faricimab InjectionPatients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks (Week 20 Visit), followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks. |
| Group 2, 12-Week | Experimental | Drug: Faricimab InjectionPatients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval (Week 24 Visit). Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Active treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA
- BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye
- presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT
- patient capable of signing the informed consent
Key exclusion criteria (15 listed)
- Myocardial Infarction or Stroke in the last 3 months
- subretinal haemorrhage comprising more than 25% of the lesion in the study eye
- scar or fibrosis comprising more than 50% of the lesion in the study eye
- presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
- total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faricimab InjectionIntravitreal Injection | Drug | Group 1, 8-Week, Group 2, 12-Week |
Primary outcome
Change in CRT
Time frame: from baseline up to 56 weeks
Change in central subfield thickness (CST) over time as measured by SD-OCT
Patients with intraretinal or subretinal fluid or serous pigment epithelium detachment after loading
Time frame: From baseline to week 20 (Group 1) or week 24 (Group 2)
Number of patients with subretinal, intraretinal fluid or pigment epithelium detachment (PED) at week 20 (Group 1) or week 24 (Group 2)
4 secondary outcomes
Change from baseline in BCVA
Time frame: From baseline up to 56 weeks
Presence of fluid
Time frame: From baseline up to 56 weeks
Number of injections
Time frame: From baseline up to 56 weeks
Treatment interval
Time frame: From baseline up to 56 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Pencak, MD principal investigator
+420 267 16 3637
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Faricimab Injection in people with Wet Age-related Macular Degeneration, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. 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 Czechia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Pencak, MD (+420 267 16 3637, martin.pencak@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CRT (time frame: from baseline up to 56 weeks). 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?
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 13 Mar 2025.