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

Primary Purpose

Neovascular(Wet) Age Related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-701
Lucentis®
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular(Wet) Age Related Macular Degeneration focused on measuring Neovascular(wet) Age related Macular Degeneration, CKD-701

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CKD-701

Lucentis®

Arm Description

Drug: CKD-701 (proposed ranibizumab biosimilar)

Drug: Lucentis® (ranibizumab)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean change in the best-corrected visual acuity (BCVA) score from baseline to 3 months, 6 months and 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
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
Change in the Central Retinal Thickness(CRT) at 1 months, 3 months, 6 months, 12months versus baseline
The proportion of patients with the absence of intraretinal fluid and subretinal fluid at 3 months, 6 months, 12months versus baseline

Full Information

First Posted
April 21, 2021
Last Updated
April 22, 2021
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04857177
Brief Title
A Study To Evaluate CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
March 17, 2021 (Actual)
Study Completion Date
March 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular(Wet) Age Related Macular Degeneration
Keywords
Neovascular(wet) Age related Macular Degeneration, CKD-701

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CKD-701
Arm Type
Experimental
Arm Description
Drug: CKD-701 (proposed ranibizumab biosimilar)
Arm Title
Lucentis®
Arm Type
Active Comparator
Arm Description
Drug: Lucentis® (ranibizumab)
Intervention Type
Drug
Intervention Name(s)
CKD-701
Intervention Description
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
Intervention Name(s)
Lucentis®
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Mean change in the best-corrected visual acuity (BCVA) score from baseline to 3 months, 6 months and 12 months
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
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
Time Frame
Baseline, 6 months, 12 months
Title
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
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in the Central Retinal Thickness(CRT) at 1 months, 3 months, 6 months, 12months versus baseline
Time Frame
Baseline, 1 months, 3 months, 6 months, 12 months
Title
The proportion of patients with the absence of intraretinal fluid and subretinal fluid at 3 months, 6 months, 12months versus baseline
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeong Gon Yu, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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