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

Phase 3

Completed

• Conditions: Neovascular(Wet) Age Related Macular Degeneration
• Interventions: Drug: CKD-701; Drug: Lucentis®

• Registration Number: NCT04857177
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2018-10-19
• Primary Completion: 2021-03-17
• Study Completion: 2021-03-17
• Status Verified: 2021-04
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-23
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-701	CKD-701	Drug: CKD-701 (proposed ranibizumab biosimilar)
Lucentis®	Lucentis®	Drug: Lucentis® (ranibizumab)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of