Status:
COMPLETED
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit
Lead Sponsor:
Sandoz
Conditions:
Neovascular Age-related Macular Degeneration (nAMD)
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual partici...
Detailed Description
Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea USPI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. ...
Eligibility Criteria
Inclusion
- Patients ≥ 50 years of age at baseline
- Patients diagnosed with nAMD (uni- or bilateral)
- Patients already under IVT Eylea treatment (last injection of the induction period or maintenance phase)
- Willing and able to comply with all study procedures, and be likely to complete the study
- Signed informed consent must be obtained before any assessment is performed
Exclusion
- Active, suspected or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye at baseline, which is of clinical significance according to the investigator's judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis
- Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as IOP ≥ 26 mmHg, despite treatment with anti-glaucomatous medication)
- History of a medical, ocular or non-ocular condition, that in the judgment of the investigator, would preclude a safe administration of investigational product
- Visual acuity Score (VAS) worse than 20/200 on a Snellen chart, the generally accepted level of legal blindness
- Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening
- Systemic treatment with long-acting corticosteroids (more than 10 mg prednisolone equivalent) within 3 months prior to screening Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
- Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye any time during the past 3 months
- Receipt of any systemic anti-VEGF within the last 6 months prior to enrollment
- Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening)
- Participants who do not comply with the local COVID-19 regulations of the study site
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05282004
Start Date
May 16 2022
End Date
September 7 2022
Last Update
May 10 2023
Active Locations (5)
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1
Sandoz Investigational Site
Poway, California, United States, 92064
2
Sandoz Investigational Site
Marietta, Georgia, United States, 30060
3
Sandoz Investigational Site
Oak Forest, Illinois, United States, 60452
4
Sandoz Investigational Site
Liverpool, New York, United States, 13088