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If the subject who has nAMD voluntarily agrees to participate in this clinical study by signing the informed consent form, screening assessments will be conducted within 4 weeks prior to the first dose of the investigational drug. During the screening visit, the eligibility of the subject will be assessed and one study eye will be selected. If both eyes are eligible, the eye with the worst best-corrected visual acuity (BCVA) at screening will be chosen. However, if the investigator determines that the other eye requires more urgent treatment for clinical reasons, that eye may be selected as the study eye.
After screening assessments and evaluation based on inclusion/exclusion criteria, eligible subjects will be enrolled. Vabysmo® 6 mg (0.05 mL) will be administered via intravitreal injection every 4 weeks (monthly) for a total of 4 doses during the initial loading period. After the loading dose, patients will undergo disease activity assessment based on imaging and visual acuity (VA) outcomes followed by the IP administration at Week 20. The treatment interval will be determined based on disease activity assessed at Week 20, depending on the results, the subsequent administration may be scheduled at Week 28 or Week 32, at the investigator's discretion. Thereafter, the dosing interval may be further adjusted in 4-week increments, either extended or shortened, according to imaging and visual outcomes.
Throughout the clinical study, patients will need to visit the study site at least 10 times, including the screening visit. The number of intravitreal injections administered will be 4 doses during the initial loading period and up to 5 doses during the treat-and-extend (T&E) period (Weeks 20, 28, 36, 44, 52). Thus, the total number of injections during the study will range from a minimum of 7 to a maximum of 9 injections.
If the non-study eye also has nAMD, treatment with a locally approved therapy may be administered outside the scope of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Faricimab | Experimental | Faricimab injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faricimab Injection [Vabysmo] | Drug | Faricimab Injection 6mg 0.05 cc |
|
| Measure | Description | Time Frame |
|---|---|---|
| ANG-2 level in aqueous humour (AH) | Measurement of ANG-2 levels in aqueous humor (AH) and the change from baseline to week 20 | at Week 20 from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial ANG-2 level in aqueous humour (AH) | Changes of endothelial ANG-2 level in aqueous humour (AH) at visits compared from baseline at Weeks 4, 12, 20 and 52 | At weeks 4, 12, 20 and 52 from baseline |
| BCVA measurement |
| Measure | Description | Time Frame |
|---|---|---|
| AH biomarkers and imaging biomarkers | Correlation between AH biomarkers and imaging biomarkers | From baseline to Week 52(EOS) |
| AH biomarkers and the maximum treatment interval | Correlation between AH biomarkers and the maximum treatment interval achieved during the T&E period |
Inclusion Criteria:
Ocular Conditions
Exclusion Criteria:
Ocular Conditions
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junyeop Lee, PhD | Contact | 82-2-3010-3975 | j.lee.amc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Junyeop Lee, PhD | Asan Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000723200 | faricimab |
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Best Corrected Visual Acuity (BCVA) change from baseline at Weeks 20 and 52
| At weeks 20 and 52 from baseline |
| Subfoveal choroidal thickness | Change in subfoveal choroidal thickness at Weeks 20 and 52 compared to baseline (limited to PCV patients) | At weeks 20 and 52 from baseline |
| Central subfield thickness (CST) | Central subfield thickness (CST) change from baseline at Weeks 20 and 52 | At weeks 20 and 52 from baseline |
| Intraretinal microaneurysms and vessel density of the deep capillary plexus | Change in the number of intraretinal microaneurysms and vessel density of the deep capillary plexus at Weeks 20 and 52 compared to baseline | At weeks 20 and 52 from baseline |
| Area of peripheral non-perfusion in the retina | Change in the area of peripheral non-perfusion in the retina at Weeks 20 and 52 compared to baseline | At weeks 20 and 52 from baseline |
| High improvement in vascular stabilization | Proportion of patients who achieved high improvement in vascular stabilization at Week 20 (defined as 2 or more score in Macular Neovascularization Stabilisation Scoring System Score range 0-4, higher scores mean a better outcome) | from baseline at Weeks 20 |
| Complete polyp regression | Proportion of subjects who experienced complete polyp regression at least once by Weeks 20 and 52 compared to baseline (limited to PCV patients) | At weeks 20 and 52 from baseline |
| Polyp inactivation | Proportion of subjects who experienced polyp inactivation at least once by Weeks 20 and 52 compared to baseline (limited to PCV patients) | At weeks 20 and 52 from baseline |
| Resolution of central Intraretinal fluid/Subretinal fluid(IRF/SRF) | Proportion of subjects with resolution of central IRF/SRF at Weeks 20 and 52 compared to baseline | At weeks 20 and 52 from baseline |
| Vascular remodeling | Proportion of subjects who experiences vascular remodeling with changes in choroidal angiographic features at Weeks 20 and 52 compared to baseline | At weeks 20 and 52 from baseline |
| Number of injections per patient | Mean number of injections per patient | From baseline to Week 52(EOS) |
| Treatment interval | Proportion of subjects who achieved a treatment interval of ≥12 or 16 weeks at least once during the Treat & Extend period | From baseline to Week 52(EOS) |
| Maximum treatment interval | Distribution of maximum treatment interval during the Treat & Extend period | From baseline to Week 52(EOS) |
| From baseline to Week 52(EOS) |