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

NCT04857177 | Completed Phase 3

• 1 other identifier: 177AMD17019
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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

Conditions

Neovascular(Wet) Age Related Macular Degeneration

Keywords

Neovascular(wet) Age related Macular Degeneration; CKD-701

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

CKD-701

EXPERIMENTAL

Drug: CKD-701 (proposed ranibizumab biosimilar)

Drug: CKD-701

Lucentis®

ACTIVE COMPARATOR

Drug: Lucentis® (ranibizumab)

Drug: Lucentis®

Interventions

CKD-701 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.

CKD-701

Lucentis® 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.

Lucentis®

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hyeong Gon Yu, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: October 19, 2018
• Primary Completion: March 17, 2021
• Study Completion: March 17, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)