Investigation of modified treat-and-extend (mTAE) regimen using faricimab in patients with macular edema secondary to central retinal vein occlusion (CRVO)
RVOSTAR
Kondo Mineo
Mie University Hospital
2-174, Edobashi, Tsu-city, Mie
+81-59-232-1111
mineo@med.mie-u.ac.jp
Kondo Mineo
Mie University Hospital
2-174, Edobashi, Tsu-city, Mie
+81-59-232-1111
mineo@med.mie-u.ac.jp
Recruiting
April. 03, 2025
July. 01, 2025
72
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
<General Inclusion Criteria>
1. Willingness and ability to submit a signed Informed Consent Form
2. Age >= 18 years at time of signing Informed Consent Form
3. Ability and willing to take all scheduled visit and examination
<Ocular Inclusion Criteria for Study Eye>
1. Foveal center-involved macular edema due to CRVO or HRVO, diagnosed no longer than 4 months prior to the screening visit based on SD-OCT (or SS-OCT) images
CRVO or HRVO is defined by retinal hemorrhages, telangiectatic capillary bed, dilated venous system or other biomicroscopic evidence of retinal vein occlusion (neovascularization, vitreous hemorrhage) in the entire retina (CRVO) or 1/2 of the retina (HRVO).
2. Patients who have not received treatment for macular edema associated with CRVO or HRVO (including anti-VEGF intravitreal injections and steroids)
3. Patients with visual acuity test (decimal visual acuity) of >= 0.05 and <= 0.5 performed before treatment of Day 1
4. CST >= 325 micrometer on Spectralis SD-OCT or >= 315 micro meter on Cirrus SD-OCT, Topcon SD-OCT, or equivalent at screening
5. Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
<General Exclusion Criteria>
1. Systemic treatment for suspected or active systemic infection on Day 1
2. Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
3. Uncontrolled blood pressure, defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg while a patient is at rest on Day 1
4. Active cancer within the 12 months prior to screening except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of <= 6 and a stable prostate-specific antigen for > 12 months
5. Any major illness or major surgical procedure within 1 month before screening
6. Any systemic corticosteroid use (e.g., oral or injectable) within 1 month of the screening visit
7. History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of faricimab or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications in the opinion of the primary investigator or subinvestigator
8. Pregnant or breastfeeding
9. In the case of women of childbearing potential(*), dissent to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods with a failure rate of < 1% per year(**) during the treatment period and for at least 3 months after the final dose of study treatment.
* A woman considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the primary investigator or subinvestigator (e.g., Mullerian agenesis).
** Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
10. History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used during the study
11. Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals) within 3 months prior to Day 1
12. Requirement for continuous use of any medications and treatments as following
- Systemic anti-VEGF therapy
- Systemic drugs known to cause macular edema (fingolimod, tamoxifen)
- IVT anti-VEGF agents (other than faricimab) in study eye
- IVT, periocular (subtenon), or chronic topical ocular corticosteroids in study eye
- Treatment with verteporfin (Visudyne) in study eye
- Administration of micropulse and focal or grid laser in study eye
- Other experimental therapies (except those comprising vitamins and minerals)
<Ocular Exclusion Criteria for Study Eye>
1. History of previous episodes of macular edema due to CRVO or HRVO or persistent macular edema due to CRVO or HRVO diagnosed more than 4 months before screening
2. History of retinal detachment or macular hole (Stage 3 or 4)
3. Any current ocular condition which, in the opinion of the primary investigator or subinvestigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to CRVO or HRVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
4. Tractional retinal detachment, vitreomacular traction, full thickness macular hole or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye
5. Diagnosis of DR moderate non-proliferative or worse, proliferative DR, DME, nAMD, geographic atrophy, myopic choroidal neovascularization as assessed by the primary investigator or subinvestigator
6. Active rubeosis, angle neovascularization, neovascular glaucoma
7. Any cataract surgery or treatment for complications of cataract surgery with YAG laser capsulotomy within 3 months prior to Day 1
8. Any other intraocular surgery (e.g., pars plana vitrectomy, scleral buckle, glaucoma surgery, corneal transplant, or radiotherapy)
9. Macular laser (focal/grid) or panretinal photocoagulation in the study eye at any time prior to Day 1, or panretinal photocoagulation in the study eye anticipated within 3 months of study start on Day 1
10. Any prior intervention with photodynamic therapy, laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheathotomy
11. Any prior or current treatment for macular edema; macular neovascularization,including DME and nAMD; and vitreomacular-interface abnormalities, including IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, C3F8, SF6, air or periocular injection
12. Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases
<Ocular Exclusion Criteria for Both Eyes>
1. History of idiopathic or autoimmune-associated uveitis in either eye
2. Active ocular inflammation or ocular and periocular infection (including suspected) in either eye on Day 1
18age old over
No limit
Both
Macular edema associated with Central Retinal Vein Occlusion or Hemispherical Retinal Vein Occlusion
Patients participating in this study will receive faricimab 6.0 mg administered by intravitreal injection. Study period for each subject is 72 weeks, and all subjects will receive faricimab on Day1, and thereafter receive faricimab according to the criteria for the induction phase, observation phase, and maintenance phase. Regarding visit intervals, Visits will be made every 4 weeks from Day1 to W24 and from W24 onwards, patients will visit the hospital at W36 (only for patients in observation phase), W52, and W72, with visits being scheduled according to the administration interval determined according to the mTAE regimen.
Change from Baseline in best corrected visual acuity (BCVA) at Week 72 (W72)
BCVA at each measurement time point will be measured in decimal visual acuity, and the change in BCVA will be calculated by converting it to the logarithm of the minimum angle of resolution (logMAR).
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