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Wet Age-related Macular DegenerationPhase 1NCT04919096

Study of SCB-420 in Subjects With Neovascular Age-related Macular Degeneration

A Phase 1 study testing SCB-420 and Aflibercept in people with Wet Age-related Macular Degeneration, run by Clover Biopharmaceuticals AUS Pty.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a Phase 1, randomized, double-masked, multicenter, parallel-assignment, pilot study to evaluate the safety, tolerability, initial clinical effectiveness, pharmacokinetics (PK), and immunogenicity of SCB-420 as compared with Eylea (aflibercept), in subjects with Neovascular Age-related Macular Degeneration. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
SCB-420 and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2022to Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Male or female ≥ 50 years of age.
  • Willing and able to provide written informed consent prior to any study procedure. Willing and able to comply with all protocol requirements, schedules, and procedures.
  • Treatment-naïve, active choroidal subfoveal neovascularization lesions secondary to Age-related Macular Degeneration (AMD) evidenced by Fluorescein Angiography (FA) and Indocyanine Green Angiography (ICGA) (including PCV) in the study eye evidenced by subfoveal FA/ICGA leakage, or definite subfoveal fluid by spectrum domain optical coherence tomography (SD-OCT) at screening by the Study Doctor but confirmed by the independent image reading center.
  • Active Choroidal neovascularization (CNV) area occupies at least 50% of the total lesion area in the study eye.
  • Total lesion area (including blood, scars, and vascularization) is ≤9.0 Disc Areas (DA) in the study eye.
  • Best corrected visual acuity (BCVA) letter score of 78 to 25 inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts or 2702 series number charts in the study eye at screening and at Day 1 prior to randomization (20/32 to 20/320 Snellen equivalent). The fellow (non-study) eye should not have BCVA letter score less than 19 letters (20/400 Snellen equivalent).
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  • Women of childbearing potential with a negative serum pregnancy test at screening must agree to use protocol-defined methods of contraception for 30 days prior to the first dose of the study and throughout the study until 3 months after the last injection of Eylea or SCB-420.
  • Males with female partners of childbearing potential must agree to use protocol-defined methods of contraception and agree to refrain from donating sperm throughout the study until 3 months after the last injection of Eylea or SCB-420.
  • Have ocular media (lens, cornea, vitreous) of adequate clarity to permit high quality fundus imaging.

Who cannot join

  • Study Eye
  • Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 Disc Areas (DA) or more involving the center of fovea.
  • Have scarring or fibrosis making up greater than 50% of total lesion in the study eye at screening; and/or scarring, fibrosis or atrophy involving the center of the fovea in the study eye at screening.
  • Choroidal neovascularization due to other causes, such as ocular histoplasmosis, trauma, punctate inner choroidopathy/multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia.
  • History of macular hole of Stage 2 and above.
  • Macular pathology other than Age-related Macular Degeneration that might compromise central vision, i.e., vitreomacular traction or significant epiretinal membrane. Polypoid choroidal vasculopathy identified on screening ICGA is not exclusionary.
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  • Presence of retinal pigment epithelial tears or rips involving the macula.
  • History of any vitreous hemorrhage in the study eye within 8 weeks prior to the screening visit.
  • History of retinal detachment, treatment, or surgery for retinal detachment in the study eye.
  • Uncontrolled ocular hypertension (defined as Intraocular Pressure (IOP) ≥22 mmHg despite treatment with anti-glaucoma medication) at screening.
  • Significant media opacities, including Lens Opacities Classification System (LOCS) II Grade IV cataract in the study eye, or other significant cataract in the study eye that in the investigator's opinion interferes with visualization of retina or interferes with retinal imaging.
  • Aphakia or absence of the posterior capsule (unless it occurred as a result of a yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber Intraocular Lens (IOL) implantation) in the study eye.
  • History or evidence of any other clinically significant disorder, condition or disease (e.g., co-existence of retinal vein occlusion (RVO), radiation retinopathy, diabetic retinopathy, glaucoma under treatment) in the study eye that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedure or complication.
  • Have active intraocular inflammation in either eye at screening or upon examination at baseline or a history of uveitis in either eye.
  • Have active ocular or periocular infection in either eye, or a history of any ocular or periocular infection within the 2 weeks prior to screening in either eye.
  • Study Eye - Ocular Treatment/Surgical History
  • Any prior ocular or systemic treatment, surgery, or investigational product for neovascular Age-related Macular Degeneration, including anti-vascular endothelial growth factor (anti-VEGF) therapy, except dietary supplements or vitamins.
  • Prior treatment with intravitreal (IVT) anti-VEGF therapy for any other indication.
  • Have participated as a subject in any interventional clinical trial within 1 month (30 days) prior to the baseline visit.
  • History of vitrectomy or treatment of the macula with verteporfin (photodynamic therapy), transpupillary thermotherapy, radiation therapy, or retinal laser treatment (e.g., focal laser photocoagulation) in the study eye.
  • History of laser therapy of the macula.
  • History of glaucoma-filtering surgery within 3 months of Day 1 in the study eye. Anti-glaucoma laser surgeries are allowed.
  • History of corneal transplant or presence of a corneal dystrophy that interferes with intraocular pressure measurements or imaging in the study eye.
  • Any other intraocular or periocular surgery within 3 months prior to Day 1. Lid surgery prior to 1 month of Day 1 is allowed. Uncomplicated neodymium-doped yttrium aluminium garnet (Nd:YAG) laser capsulotomy performed for secondary opacification of the posterior capsule in IOL-implanted eye within 3 months prior to Day 1 is allowed.
  • History of intravitreal or periocular injections of corticosteroids within 6 months prior to screening in the study eye or device implantation in the prior 36 months.
  • Have any use of long acting intraocular steroids, including implants, within 6 months prior to Day 1, baseline.
  • Either Eye
  • History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME), or any other vascular disease affecting the retina, other than Age-related Macular Degeneration in either eye.
  • Active intraocular inflammation or active or suspected ocular or periocular infection, within 2 weeks before Day 1.
  • Active scleritis or episcleritis or presence of scleromalacia.
  • Other
  • Uncontrolled hypertension defined as systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg under appropriate antihypertensive treatment.
  • Thrombotic event(s) (e.g., stroke, transient ischemic attacks, pulmonary embolism, deep vein thrombosis, or myocardial infarction) within 6 months of screening.
  • History or evidence of cardiac conditions, including congestive cardiac failure leading to marked limitation on physical activity, or inability to perform any physical activity without discomfort, ventricular arrhythmia requiring ongoing treatment, and atrial fibrillation.
  • Prior treatment with systemic anti-vascular endothelial growth factor (anti-VEGF) therapy.
  • Any concomitant or prior treatment with ethambutol (2 weeks prior to Day 1); deferoxamine and topiramate (4 weeks prior to Day 1); tamoxifen, hydroxychloroquine, chloroquine, or vigabatrin (8 weeks prior to Day 1), and amiodarone (12 weeks prior to Day 1).
  • Any investigational product administered for the treatment of neovascular Age-related Macular Degeneration prior to screening; and any investigational product (except dietary supplements, minerals or vitamins) for the treatment of ocular diseases or systemic diseases 30 days or 5 half-lives (whichever is longer), prior to screening, (see Table 5-1 for the list of prohibited medications).
  • Any prior or ongoing systemic medical condition (including but not limited to infectious, inflammatory, psychiatric, neurological, renal, hepatic, respiratory conditions or malignancies) or clinically significant screening laboratory value that in the opinion of the investigator may present a safety risk, interfere with study compliance and follow-up, or confound data interpretation throughout the study period.
  • Hypersensitivity to aflibercept, any of the excipients in SCB-420 or Eylea, or medications used during study procedures, (fluorescein, mydriatic eye drops, etc.), or any contraindication to study procedures or intravitreal injections, according to investigator judgment.
  • Any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography.

About this study

Official title: A Phase 1, Randomized, Double-Masked, Parallel Group, Multicenter, Pilot Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SCB-420 and Eylea® in Subjects With Neovascular Age-related Macular Degeneration

This is a Phase 1, randomized, double-masked, multicenter, parallel-assignment, pilot study to evaluate the safety, tolerability, initial clinical effectiveness, pharmacokinetics (PK), and immunogenicity of SCB-420 as compared with Eylea (aflibercept), in subjects with Neovascular Age-related Macular Degeneration.

A total of 20 subjects with Neovascular Age-related Macular Degeneration will be enrolled across up to 11 sites in 3 countries (Australia, New Zealand, and China). The study will be conducted in 2 parts - Sentinel Safety Cohort and Open Enrolment. Subjects will be administered with 2 mg of SCB-420 or Eylea via intravitreal (IVT) injection every 4 weeks for a total 3 doses.

Being tested
SCB-420, Aflibercept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCB-420Drug

    Subjects randomised to SCB-420 arm will receive a total of 3 doses of SCB-420 as an intravitreal injection of 2 mg into the study eye every 4 weeks on Day 1, Week 4, and Week 8.

  • AfliberceptDrug

    Also called Eylea

    Subjects randomised to Aflibercept arm will receive a total of 3 doses of Aflibercept as an intravitreal injection of 2 mg into the study eye every 4 weeks on Day 1, Week 4, and Week 8.

Study groups in NCT04919096
Study groupRoleWhat they receive
SCB-420ExperimentalSubjects randomized to SCB-420 will receive SCB-420 2mg (0.05 mL) via intravitreal injection in the study eye every 4 weeks for the first 3 months.
Receives: Drug: SCB-420
AfliberceptActive comparatorSubjects randomized into Aflibercept (Eylea) group will receive Aflibercept (Eylea) 2 mg (0.05 mL) via intravitreal injection in the study eye every 4 weeks for the first 3 months.
Receives: Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ocular and non-ocular adverse events.

    Collection of any ocular and non-ocular adverse events.

    Measured: Baseline to Week 12

Secondary outcomes (10)

  1. Change from baseline in Best Corrected Visual Acuity (BCVA)

    Change from baseline in Best Corrected Visual Acuity (BCVA)

    Measured: Baseline to Week 12

  2. Change in central foveal thickness (CFT)

    Change in central foveal thickness (CFT)

    Measured: Baseline to Week 12

  3. Percentage Change from baseline in the area of Choroidal neovascularization (CNV) lesions in Neovascular Age-related Macular Degeneration or polyps in Polypoidal choroidal vasculopathy

    Change in Choroidal neovascularization (CNV) lesions in Neovascular Age-related Macular Degeneration or polyps in Polypoidal choroidal vasculopathy

    Measured: Baseline to Week 12

  4. Observe serum concentration of free and total SCB 420 and Eylea

    Pharmacokinetic (PK) parameter area under the concentration versus time curves (AUC)

    Measured: Baseline to Week 8

  5. Observe maximum concentration (Cmax) of free and total SCB 420 and Eylea

    Pharmacokinetic (PK) parameter: Maximum concentration (Cmax)

    Measured: Baseline to Week 8

  6. Observe minimum concentration (Cmin) of free and total SCB 420 and Eylea

    Pharmacokinetic (PK) parameter: Minimum concentration (Cmin)

    Measured: Baseline to Week 8

  7. Observe Time to Maximum concentration (Tmax) of free and total SCB 420 and Eylea

    Description: Pharmacokinetic (PK) parameter: Time to maximum concentration (Tmax)

    Measured: Baseline to Week 8

  8. Observe Elimination Half Life (T1/2) of free and total SCB 420 and Eylea

    Pharmacokinetic (PK) parameter: Elimination Half Life (T1/2)

    Measured: Baseline to Week 8

  9. Titer of anti-drug antibodies (ADAs) against SCB-420 and Eylea at predose on Day 1, Week 4, and Week 8

    Titer of anti-drug antibodies (ADAs) against SCB-420 and Eylea at predose on Day 1, Week 4, and Week 8

    Measured: Baseline to Week 8

  10. Neutralizing antibodies testing in confirmed ADA positive subjects

    Neutralizing antibodies testing in confirmed ADA positive subjects

    Measured: Baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study startApr 2022 (estimated)
  3. Primary completionSep 2022 (estimated)
  4. Study completionJan 2023 (estimated)

Why it stopped: Due to an internal decision to prioritise its development pipeline, Clover have decided to close down study CLO-SCB-420-001. This was a corporate decision and not the results of new data or information arising related to SCB-420

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04919096
Sponsor's protocol ID
CLO-SCB-420-001
Status last verified
Apr 2022
First submitted
18 May 2021
Last updated
19 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCB-420 and Aflibercept in people with Wet Age-related Macular Degeneration, run by Clover Biopharmaceuticals AUS Pty.

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 9 inclusion and 40 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: withdrawn, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of ocular and non-ocular adverse events. (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04919096.

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 19 Apr 2022.

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