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

NCT04919096 | Withdrawn Phase 1

• 1 other identifier: CLO-SCB-420-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Incidence of ocular and non-ocular adverse events.

  Collection of any ocular and non-ocular adverse events.

  Baseline to Week 12

Secondary Outcomes (10)

• Change from baseline in Best Corrected Visual Acuity (BCVA)

  Baseline to Week 12

• Change in central foveal thickness (CFT)

  Baseline to Week 12

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

  Baseline to Week 12

• Observe serum concentration of free and total SCB 420 and Eylea

  Baseline to Week 8

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

  Baseline to Week 8

Study Arms (2)

SCB-420

EXPERIMENTAL

Subjects 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.

Drug: SCB-420

Aflibercept

ACTIVE COMPARATOR

Subjects 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.

Drug: Aflibercept

Interventions

SCB-420 DRUG

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.

SCB-420

Aflibercept DRUG

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.

Also known as: Eylea

Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Clover Biopharmaceuticals AUS Pty: lead

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 9, 2021
• Study Start: April 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: April 19, 2022

Record last verified: 2022-04