Efficacy and Safety of RC28-E Versus Aflibercept

NCT05727397 | Unknown Phase 3 DMC

• 1 other identifier: 28C004
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-masked, multicenter study comparing the the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) versus aflibercept in patients with wet age-related macular degeneration.

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in BCVA at week 48;

  BCVA=Best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  Baseline, week 48

Secondary Outcomes (11)

• Average change in BCVA from baseline over the period week 36 through week 48;

  Baseline, weeks 36, 40, 44 and 48.

• Proportion of subjects with q12w injection;

  Baseline, week 48

• Proportion of subjects with q12w injection at week 48 within the subjects with no q8w injection need at week 16, week 20;

  Week 16, 20, 48

• Proportion of subjects with gain in BCVA of 15/10/5/0 letters or more from baseline to week 48;

  Baseline, week 48

• Mean change in CST from baseline to week 16, week 48;

  Baseline, week 16, 48

Study Arms (2)

RC28-E

EXPERIMENTAL

RC28-E 2 mg will be initially injected 3 times at 4 week intervals, then each subject will be injected every 12 weeks unless there is disease activity. If disease activity is identified, the subject will be reassigned to receive injections every 8 weeks thereafter, up to study exit.

Drug: RC28-E

Aflibercept

ACTIVE COMPARATOR

Aflibercept 2 mg will be injected 3 times at 4 week intervals, followed by injections every 8 weeks.

Drug: Aflibercept

Interventions

RC28-E DRUG

Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 µL dose.

RC28-E

Aflibercept DRUG

Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 µL dose.

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:

• Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
• years of age or older;
• Diagnosed with wAMD;
• Active CNV lesion of any type (ie, predominantly classic, minimally classic, or occult \[including polypoidal choroidal vasculopathy and retinal angiomatous proliferation\]) that exhibits all of the following characteristics:
• The CNV or sequela of the CNV affect the foveal;
• A total lesion size of ≤12 disc areas on FFA;
• Evidence of CNV leakage on FFA;
• Intra and/or subretinal fluid confirmed on OCT;
• BCVA of 78-19 letters using the ETDRS protocol;
• Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good-quality retinal images to confirm diagnosis.

You may not qualify if:

• For the study eye:
• CNV due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis;
• Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid;
• Presence at screening of central serous chorioretinopathy;
• Retinal pigment epithelial tear involving the foveola on day 1;
• Fibrosis or atrophy involves the foveola;
• Subretinal haemorrhage involves the foveola;
• Any concurrent intraocular condition (eg, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study;
• Current vitreous hemonhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline;
• Uncontrolled glaucoma;
• Spherical equivalent of refractive error demonstrating ≥8 diopters of myopia;
• Previous treatment with anti-VEGF therapy within the 3 months period prior to baseline;
• Intraocular use of long-acting corticosteroids during the 6 month period prior to baseline; intraocular use of short or medium-acting corticosteroids during the 3 month period prior to baseline; periocular use of corticosteroids during the 1 month period prior to baseline;
• Use of topical ocular corticosteroids for 60 or more consecutive days within the 3 month period prior to baseline;
• Macular laser treatment, PDT, TTT or other surgical intervention for AMD within the 3 month period prior to baseline;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

RC28-E protein; aflibercept

Central Study Contacts

Binghua Xiao

CONTACT

86-010-58076833; xiaosir522@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: January 10, 2023
• First Posted: February 14, 2023
• Study Start: March 14, 2023
• Primary Completion: November 29, 2025
• Study Completion: December 29, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-02

Locations

CN (1)