A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration

Chong Kun Dang Pharmaceutical1 site in 1 country312 target enrollmentOctober 19, 2018

ConditionsNeovascular(Wet) Age Related Macular Degeneration

InterventionsCKD-701 Lucentis®

DrugsCKD-701 Lucentis®

Overview

Phase: Phase 3
Intervention: CKD-701
Conditions: Neovascular(Wet) Age Related Macular Degeneration
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 312
Locations: 1
Primary Endpoint: The proportion of patients with a decrease in the best-corrected visual acuity (BCVA) score of 15 or fewer letters at 3 months versus baseline.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, active-controlled, parallel group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients with Neovascular(wet) Age related Macular Degeneration

Detailed Description

Subjects will be randomised in a 1:1 ratio to receive either CKD-701 or Lucentis®. Investigational Products (IP) (CKD-701 or Lucentis®) will be administered once a month during the loading phase(the first three months), and for the next nine months(PRN phase), administion will be determined based on the PRN administration criteria.

Registry

clinicaltrials.gov

Start Date

October 19, 2018

End Date

March 17, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥50 years
•Presence in the study eye of active subfoveal CNV lesion due to AMD
•The total lesion size ≤ 12 DA in the study eye
•The presence of CNV foci of more than 50% of the total lesion area in the study eye
•The best-corrected visual acuity within a range from 78 to 34 letters (20/32\~20/200) measured using the ETDRS chart in the study eye
•Written informed consent

Exclusion Criteria

•Any previous anti-vascular endothelial growth factor(anti-VEGF) treatment to treat neovascular AMD
•Presence of eye-related inflammation or infection, such as Infectious ophthalmitis, corneal inflammation, conjunctivitis (including scleromalacia), endocular inflammation
•Any history or clinical basis of disease affecting the retina except age-related macular degeneration(AMD), such as diabetic retinopathy, diabetic macular edema
•Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, angioid streaks retinopathy or pathologic myopia
•Patients with macular abnormalities other than age-related macular degeneration (AMD)

Arms & Interventions

CKD-701

Drug: CKD-701 (proposed ranibizumab biosimilar)

Intervention: CKD-701

Lucentis®

Drug: Lucentis® (ranibizumab)

Intervention: Lucentis®

Outcomes

Primary Outcomes

The proportion of patients with a decrease in the best-corrected visual acuity (BCVA) score of 15 or fewer letters at 3 months versus baseline.

Time Frame: Baseline to 3 months

Secondary Outcomes

The proportion of patients with a decrease in the best-corrected visual acuity (BCVA) score of 15 or fewer letters at 6 months, 12 months versus baseline(Baseline, 6 months, 12 months)
The proportion of patients with an increase in the best-corrected visual acuity (BCVA) score of 15 or more letters at 3 months, 6 months, 12months versus baseline(Baseline, 3 months, 6 months, 12 months)
Mean change in the best-corrected visual acuity (BCVA) score from baseline to 3 months, 6 months and 12 months(Baseline, 3 months, 6 months, 12 months)
Change in the Central Retinal Thickness(CRT) at 1 months, 3 months, 6 months, 12months versus baseline(Baseline, 1 months, 3 months, 6 months, 12 months)
The proportion of patients with the absence of intraretinal fluid and subretinal fluid at 3 months, 6 months, 12months versus baseline(3 months, 6 months, 12 months)