Phase 3
Completed N=30
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
Neovascular Age-related Macular Degeneration (nAMD)
Source: ClinicalTrials.gov NCT05161806 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Number of Participants With Ocular Treatment Emergent Adverse Events — 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Ocular Treatment Emergent Adverse Events |
2 | — |
| PRIMARY Number of Participants With Non-ocular Treatment Emergent Adverse Events |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects ≥ 50 years of age at baseline
- Subjects diagnosed with nAMD (uni- or bilateral)
- Subjects already under IVT Eylea treatment (last injection of the induction period or maintenance phase)
Exclusion Criteria
- Active 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 intraocular pressure (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
- 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)
- Subjects who do not comply with the local COVID-19 regulations of the study site
Data sourced from ClinicalTrials.gov (NCT05161806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.