Neovascular Age-related Macular Degeneration (nAMD)Phase 3NCT05161806
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
A Phase 3 study testing SOK583A1 (40 mg/mL) and Prefilled Syringe (PFS) in people with Neovascular Age-related Macular Degeneration (nAMD), run by Sandoz at 3 sites in United States.
Trial summary
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration (nAMD)
- What is being tested?
- SOK583A1 (40 mg/mL) and Prefilled Syringe (PFS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Mar 2022to 4 May 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sandoz Investigational Site
Liverpool, New York, 13088
Sandoz Investigational Site
Marietta, Georgia, 30060
Sandoz Investigational Site
Oak Forest, Illinois, 60452
About this study
Official title: An Open-label, Single-arm, Multicenter Study in Patients With Neovascular Age-related Macular Degeneration to Evaluate the Safety of SOK583A1 (40 mg/mL), a Proposed Aflibercept Biosimilar Product, Provided in a Prefilled Syringe
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
Read the detailed description
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with nAMD, eligible for Intravitreal (IVT) aflibercept treatment.
Screening and Baseline could be performed on the same day.
Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea US PI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. Only subjects already under IVT Eylea treatment and hence familiar with the IVT procedure were eligible for the study. Administration of the study treatment was embedded into their individual dosing schedule.
Demonstration of the safe use of the PFS containing SOK583A1 was based on the performance of at least 3 different ophthalmologist teams.
Follow-up visits were performed on-site on Day 8 (±2 days) and on Day 31 (+4 days - end of study visit). Subjects participated for 30 to 34 days in the study including Baseline and treatment on Day 1 (Screening and Baseline could be performed on the same day) and the last safety follow-up on Day 31 (a time window of plus 4 days was allowed for the last safety follow-up).
- Being tested
- SOK583A1 (40 mg/mL), Prefilled Syringe (PFS)
- Keywords
- Open label study,, intravitreal injection,, biosimilar,, aflibercept,, PFS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOK583A1 (40 mg/mL)Drug
Also called aflibercept
SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration
Prefilled Syringe (PFS)Device
Prefilled Syringe (PFS)
| Study group | Role | What they receive |
|---|---|---|
| SOK583A1 (40 mg/mL) | Experimental | participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study Receives: Drug: SOK583A1 (40 mg/mL); Device: Prefilled Syringe (PFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Ocular Treatment Emergent Adverse Events
Number of participants with ocular treatment emergent adverse events were reported.
Measured: throughout the study, approximately 31 days
Number of Participants With Non-ocular Treatment Emergent Adverse Events
Number of participants with non ocular Treatment emergent adverse events were reported.
Measured: throughout the study, approximately 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start11 Mar 2022
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161806
- Sponsor's protocol ID
- CSOK583A12304
- Status last verified
- Oct 2022
- First submitted
- 15 Dec 2021
- Last updated
- 18 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter Study in Patients With Neovascular Age-related Macular Degeneration to Evaluate the Safety of SOK583A1 (40 mg/mL), a Proposed Aflibercept Biosimilar Product, Provided in a Prefilled Syringe
- ClinicalTrials.gov ID
- NCT05161806
- Acronym / sponsor ID
- CSOK583A12304
- Keywords
- Open label study,, intravitreal injection,, biosimilar,, aflibercept,, PFS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Posted 18 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
Detailed description
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with nAMD, eligible for Intravitreal (IVT) aflibercept treatment.
Screening and Baseline could be performed on the same day.
Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea US PI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. Only subjects already under IVT Eylea treatment and hence familiar with the IVT procedure were eligible for the study. Administration of the study treatment was embedded into their individual dosing schedule.
Demonstration of the safe use of the PFS containing SOK583A1 was based on the performance of at least 3 different ophthalmologist teams.
Follow-up visits were performed on-site on Day 8 (±2 days) and on Day 31 (+4 days - end of study visit). Subjects participated for 30 to 34 days in the study including Baseline and treatment on Day 1 (Screening and Baseline could be performed on the same day) and the last safety follow-up on Day 31 (a time window of plus 4 days was allowed for the last safety follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOK583A1 (40 mg/mL) | Experimental | Drug: SOK583A1 (40 mg/mL), Device: Prefilled Syringe (PFS)participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOK583A1 (40 mg/mL)Also: afliberceptSOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration | Drug | SOK583A1 (40 mg/mL) |
| Prefilled Syringe (PFS)Prefilled Syringe (PFS) | Device | SOK583A1 (40 mg/mL) |
Primary outcome
Number of Participants With Ocular Treatment Emergent Adverse Events
Time frame: throughout the study, approximately 31 days
Number of participants with ocular treatment emergent adverse events were reported.
Number of Participants With Non-ocular Treatment Emergent Adverse Events
Time frame: throughout the study, approximately 31 days
Number of participants with non ocular Treatment emergent adverse events were reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SOK583A1 (40 mg/mL) and Prefilled Syringe (PFS) in people with Neovascular Age-related Macular Degeneration (nAMD), run by Sandoz at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Ocular Treatment Emergent Adverse Events (time frame: throughout the study, approximately 31 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.