Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration

NCT03777254 | Completed Phase 1

• 1 other identifier: C001AMDCLLI
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this first-in-human study is to evaluate the safety, tolerability and pharmacokinetics of single intravitreous injections,single ascending doses, of RC28-E(a chimeric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in subjects with wet age-related macular degeneration (wAMD).

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Incidence of ocular and systemic adverse events and serious adverse events which are related to RC28-E

  42 days

Secondary Outcomes (6)

• Area under the plasma concentration-time curve(AUC)

  42 days

• Maximum observed maximum plasma concentration (Cmax)

  42 days

• Time to reach the maximum observed plasma concentration (Tmax)

  42 days

• T1/2(Terminal phase half life after single dose)

  42 days

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

  42 days

Study Arms (1)

RC28-E

EXPERIMENTAL

"·Experimental:RC28-E 0.25mg Injection:single Intravitreal Injection Intervention: Biological: RC28-E * Experimental: RC28-E 0.5mg Injection:single Intravitreal Injection Intervention: Biological: RC28-E * Experimental: RC28-E 1.0mg Injection:single Intravitreal Injection Intervention: Biological: RC28-E * Experimental: RC28-E 2.0mg Injection:single Intravitreal Injection Intervention: Biological: RC28-E"

Biological: RC28-E

Interventions

RC28-E BIOLOGICAL

RC28-E intravitreous injection 50ul

Also known as: RC28-E is a chimeric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2.

RC28-E

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients or their legal representative signed informed consent;
• Aged 50 years to 80 years, male or female;
• Best corrected VA for the studied eye≥34 letters, ≤73 letters(By ETDRS chart);
• With choroidal neovascular (CNV) lesions secondary to neovascular AMD;
• If both eyes meet the criteria, severe illness eye will be selected; if both eyes are the same, the right eye will be selected as the study eye.

You may not qualify if:

• History of any vitreous hemorrhage with 2 months prior to screening;
• Presence of scar, fibrosis or atrophy in central foveal of the study eye;
• Significant refractive media opacity, including cataract, may interfere with visual assessment;
• The studied eye suffered pseudoexfoliation syndrome, central retinal vein occlusion, intraocular hemorrhage resulting in decreased vision, rhegmatogenous retinal detachment, macular hole, choroidal neovascularization (CNV) for any reason other than AMD (such as fundus angioid streaks, ocular histoplasmosis, pathologic myopia, trauma);
• Afferent pupillary defect(APD);
• The intraocular pressure is higher than 25mmHg despite medication treatment;
• Active infectious conjunctivitis, keratitis, scleritis, uveitis and endophthalmitis;
• Best corrected VA for the studied eye≤19 letters(By ETDRS chart);
• Topical or grid photocoagulation within 3 months before screening;
• Uncontrolled diabetes mellitus(fast glucose level≥7.0 mmol/L or ≥11.1 mmol/L 2h after meal;
• The studied eye received any intraocular surgery or laser treatment (such as macular translocation surgery, glaucoma filtering surgery, transpupillary thermotherapy, foveal photocoagulation surgery, vitrectomy, optic neurotomy, optic nerve sheath fenestration; But cataract surgery, verteporfin photodynamic therapy, Nd:YAG laser posterior capsulotomy more than 3 months before screening can be selected;
• Any eye or whole body received anti-angiogenic drug such as pegaptanib, Aflibercept, Ranibizumab, Bevacizumab,conbercept within 3 months before baseline visit;
• Any eye received intraocular injection of corticosteroid drugs (such as triamcinolone acetonide) within 3 months before screening, or periocular injection of corticosteroid drugs within 1 months before screening;
• Allergic to sodium fluorescein, indocyanine green, therapeutic or diagnostic protein products, and allergic ≥2 drugs and/or non-drugs, or with current allergic diseases;
• With surgery within one month prior to enrollment, or with unhealed wound, ulcer, fracture at present;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Beijing Tongren Hospital .Cmu

Beijing, 100730, China

Location

Related Publications (1)

• Kou X, Sun Y, Li S, Bian W, Liu Z, Zhang D, Jiang J. Pharmacology Study of the Multiple Angiogenesis Inhibitor RC28-E on Anti-Fibrosis in a Chemically Induced Lung Injury Model. Biomolecules. 2019 Oct 24;9(11):644. doi: 10.3390/biom9110644.

  PMID: 31652997 DERIVED

MeSH Terms

Interventions

RC28-E protein; Fibroblast Growth Factor 2

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• wenbin wei

  BEIJING TONGREN HOSPITAL.CMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 17, 2018
• Study Start: January 7, 2019
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

CN (1)