Clinical Trials List
Protocol NumberMR45638
Active
2025-02-03 - 2029-12-31
Others
Recruiting3
ICD-10H35.32
Exudative age-related macular degeneration
ICD-9362.52
Exudative senile macular degeneration
A PHASE IIIB/IV, MULTICENTER, RANDOMIZED, OPEN-LABEL, TWO-ARM STUDY TO INVESTIGATE THE EFFICACY, SAFETY, AND DURABILITY OF FARICIMAB ADMINISTERED UP TO EVERY 24 WEEKS IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (CONSTANCE)
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Trial Applicant
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Sponsor
Roche Products Ltd
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- TSO-TING LAI Division of Ophthalmology
- CHANG-HAO YANG Division of Ophthalmology
- 謝易庭 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 孟平平 Division of Ophthalmology
- 陳文祿 Division of Ophthalmology
- 顧蔚寧 Division of Ophthalmology
- Peng-Tai Tien Division of Ophthalmology
- 夏寧憶 Division of Ophthalmology
- 謝明潔 Division of Ophthalmology
- 林正明 Division of Ophthalmology
- 王奕 Division of Ophthalmology
- Chun-JU Lin Division of Ophthalmology
- 賴俊廷 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yo-Chen Chang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Evaluate the efficacy of intravitreal (IVT) faricimab in the study eye for each treatment group, based on the mean change from baseline in best-corrected visual acuity (BCVA) at Weeks 44, 48, and 52.
Objectives
Evaluate the efficacy, safety, and durability of intravitreal (IVT) 6-mg faricimab administered at intervals of up to 24 weeks in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) secondary to macular neovascularization (MNV).
Test Drug
Injection
Active Ingredient
Faricimab
Dosage Form
27D
Dosage
6MG/0.05ML
Endpoints
Evaluate the efficacy of intravitreal (IVT) faricimab in the study eye for each treatment group, based on the mean change from baseline in best-corrected visual acuity (BCVA) at Weeks 44, 48, and 52.
Inclution Criteria
Potential participants will be eligible for inclusion in this study only if all of the following criteria are met:
• Signed informed consent form (ICF).
• Able to comply with the study protocol.
• Age ≥ 50 years at the time of signing the ICF.
• Judged to be in good general health based on medical evaluation, including medical history and physical examination.
• Agreement to comply with contraception requirements as described below:
– Female participants must either remain abstinent for the duration of treatment and for 3 months after the last dose of faricimab, or use a highly effective contraceptive method with a failure rate of <1% per year.
– A woman of childbearing potential (WOCBP) is defined as a woman who has experienced menarche and is neither postmenopausal (no menses for ≥12 consecutive months with no other medical cause) nor permanently sterile (i.e., no surgical removal of ovaries, fallopian tubes, and/or uterus, or other causes such as Müllerian agenesis, as determined by the investigator). Tubal ligation does not render a woman non–childbearing. This definition may be adapted per local guidelines or regulations.
– Highly effective contraceptive methods (<1% annual failure rate) include: bilateral tubal occlusion, male sterilization, hormonal contraceptives that inhibit ovulation, hormonal intrauterine devices (IUDs), and copper IUDs.
– The reliability of abstinence should be evaluated considering the study duration, participant’s lifestyle, and personal preferences.
– Periodic abstinence methods (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable.
– Where required by local regulations, the locally approved contraceptive methods and details on the reliability of abstinence will be described in the country-specific ICF.
Ocular Inclusion Criteria (Study Eye)
• Untreated active neovascular (wet) age-related macular degeneration (nAMD) secondary to macular neovascularization (MNV), confirmed by the investigator based on the presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) involving the central retina on optical coherence tomography (OCT).
• Best-corrected visual acuity (BCVA) between 83 and 24 letters inclusive on Day 1, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting testing distance of 4 meters (approximately equivalent to 20/25 to 20/320 Snellen).
– Enrollment of participants with BCVA > 78 letters will be capped at 15% of the total study population.
• Sufficiently clear ocular media and adequate pupil dilation to obtain high-quality retinal images for diagnostic confirmation.
• Signed informed consent form (ICF).
• Able to comply with the study protocol.
• Age ≥ 50 years at the time of signing the ICF.
• Judged to be in good general health based on medical evaluation, including medical history and physical examination.
• Agreement to comply with contraception requirements as described below:
– Female participants must either remain abstinent for the duration of treatment and for 3 months after the last dose of faricimab, or use a highly effective contraceptive method with a failure rate of <1% per year.
– A woman of childbearing potential (WOCBP) is defined as a woman who has experienced menarche and is neither postmenopausal (no menses for ≥12 consecutive months with no other medical cause) nor permanently sterile (i.e., no surgical removal of ovaries, fallopian tubes, and/or uterus, or other causes such as Müllerian agenesis, as determined by the investigator). Tubal ligation does not render a woman non–childbearing. This definition may be adapted per local guidelines or regulations.
– Highly effective contraceptive methods (<1% annual failure rate) include: bilateral tubal occlusion, male sterilization, hormonal contraceptives that inhibit ovulation, hormonal intrauterine devices (IUDs), and copper IUDs.
– The reliability of abstinence should be evaluated considering the study duration, participant’s lifestyle, and personal preferences.
– Periodic abstinence methods (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable.
– Where required by local regulations, the locally approved contraceptive methods and details on the reliability of abstinence will be described in the country-specific ICF.
Ocular Inclusion Criteria (Study Eye)
• Untreated active neovascular (wet) age-related macular degeneration (nAMD) secondary to macular neovascularization (MNV), confirmed by the investigator based on the presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) involving the central retina on optical coherence tomography (OCT).
• Best-corrected visual acuity (BCVA) between 83 and 24 letters inclusive on Day 1, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting testing distance of 4 meters (approximately equivalent to 20/25 to 20/320 Snellen).
– Enrollment of participants with BCVA > 78 letters will be capped at 15% of the total study population.
• Sufficiently clear ocular media and adequate pupil dilation to obtain high-quality retinal images for diagnostic confirmation.
Exclusion Criteria
Potential participants will be excluded from this study if any of the following criteria apply:
• Any major illness or surgical procedure within 1 month prior to screening.
• Active malignancy within 12 months prior to Day 1, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or prostate cancer with a Gleason score of 6 (Grade Group 1) and stable prostate-specific antigen (PSA) for more than 12 months.
• Requirement for ongoing use of any prohibited medications or treatments as defined in the study protocol.
• Systemic treatment for suspected or active systemic infection at Day 1.
– Prophylactic antibiotic use may be permitted at the investigator’s discretion. If necessary, the investigator may consult with the medical monitor to discuss individual cases.
• Uncontrolled hypertension, defined as resting systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Day 1.
– If the initial reading at screening exceeds these limits, a repeat measurement may be taken later the same day or on another screening day. If the second reading is within range, screening may continue.
– If the blood pressure on Day 1 is within range, the participant may be eligible.
– Participants taking antihypertensive medications must have been on a stable regimen for at least 30 days prior to Day 1.
• History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1.
• Any condition or abnormality (e.g., other diseases, metabolic dysfunctions, abnormal physical examination or lab results) that, in the investigator’s judgment, could contraindicate investigational drug use, affect interpretation of results, or increase the participant’s risk of complications from study treatment.
• History of severe allergic or anaphylactic reactions to biologic agents, or known hypersensitivity to any component of faricimab injection, materials used in study procedures, mydriatic agents, or anesthetics/antimicrobials used during the study.
• Participation in another investigational drug or device study (excluding vitamins and minerals) requiring systemic administration within 3 months prior to Day 1.
• Use of any other investigational therapy (including vitamins, minerals, or traditional medicines claimed to treat choroidal or macular neovascularization [CNV/MNV] or age-related macular degeneration [AMD]) within 14 days prior to randomization (Day 1).
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of study treatment.
– For women of childbearing potential, a negative urine pregnancy test is required within 28 days prior to the first dose of study treatment.
– If the urine pregnancy test is positive, a confirmatory serum pregnancy test must be performed.
(Final eligibility determination will be made by the investigator in accordance with the complete inclusion and exclusion criteria specified in the study protocol.)
• Any major illness or surgical procedure within 1 month prior to screening.
• Active malignancy within 12 months prior to Day 1, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or prostate cancer with a Gleason score of 6 (Grade Group 1) and stable prostate-specific antigen (PSA) for more than 12 months.
• Requirement for ongoing use of any prohibited medications or treatments as defined in the study protocol.
• Systemic treatment for suspected or active systemic infection at Day 1.
– Prophylactic antibiotic use may be permitted at the investigator’s discretion. If necessary, the investigator may consult with the medical monitor to discuss individual cases.
• Uncontrolled hypertension, defined as resting systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Day 1.
– If the initial reading at screening exceeds these limits, a repeat measurement may be taken later the same day or on another screening day. If the second reading is within range, screening may continue.
– If the blood pressure on Day 1 is within range, the participant may be eligible.
– Participants taking antihypertensive medications must have been on a stable regimen for at least 30 days prior to Day 1.
• History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1.
• Any condition or abnormality (e.g., other diseases, metabolic dysfunctions, abnormal physical examination or lab results) that, in the investigator’s judgment, could contraindicate investigational drug use, affect interpretation of results, or increase the participant’s risk of complications from study treatment.
• History of severe allergic or anaphylactic reactions to biologic agents, or known hypersensitivity to any component of faricimab injection, materials used in study procedures, mydriatic agents, or anesthetics/antimicrobials used during the study.
• Participation in another investigational drug or device study (excluding vitamins and minerals) requiring systemic administration within 3 months prior to Day 1.
• Use of any other investigational therapy (including vitamins, minerals, or traditional medicines claimed to treat choroidal or macular neovascularization [CNV/MNV] or age-related macular degeneration [AMD]) within 14 days prior to randomization (Day 1).
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of study treatment.
– For women of childbearing potential, a negative urine pregnancy test is required within 28 days prior to the first dose of study treatment.
– If the urine pregnancy test is positive, a confirmatory serum pregnancy test must be performed.
(Final eligibility determination will be made by the investigator in accordance with the complete inclusion and exclusion criteria specified in the study protocol.)
The Estimated Number of Participants
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Taiwan
25 participants
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Global
274 participants
