A Study To Evaluate CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration

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

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

Study Overview

• Status: Completed
• Conditions: Neovascular(Wet) Age Related Macular Degeneration
• Intervention / Treatment: Drug: CKD-701; Drug: Lucentis®

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.

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥50 years
2. Presence in the study eye of active subfoveal CNV lesion due to AMD
3. The total lesion size ≤ 12 DA in the study eye
4. The presence of CNV foci of more than 50% of the total lesion area in the study eye
5. 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
6. Written informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CKD-701; Drug: CKD-701 (proposed ranibizumab biosimilar)	Drug: CKD-701; CKD-701 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every one month during the loading phase, and intervals of one month based on criteria during the PRN phase.
ACTIVE_COMPARATOR: Lucentis®; Drug: Lucentis® (ranibizumab)	Drug: Lucentis®; Lucentis® (ranibizumab) 0.5mg via intravitreal injection every one month during the loading phase, and intervals of one month based on criteria during the PRN phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Hyeong Gon Yu, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2018
• Primary Completion (ACTUAL): March 17, 2021
• Study Completion (ACTUAL): March 17, 2021

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (ACTUAL): April 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Neovascular(wet) Age related Macular Degeneration; CKD-701
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: 177AMD17019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No