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

NCT ID: NCT04857177

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-19
• Study Completion Date: 2021-03-17

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.

Conditions

Neovascular(Wet) Age Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CKD-701

Drug: CKD-701 (proposed ranibizumab biosimilar)

Group Type: EXPERIMENTAL

CKD-701

Intervention Type: DRUG

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.

Lucentis®

Drug: Lucentis® (ranibizumab)

Group Type: ACTIVE_COMPARATOR

Lucentis®

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyeong Gon Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

177AMD17019

Identifier Type: -

Identifier Source: org_study_id