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Completed

NCT Number: NCT04857177

A Study To Evaluate 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

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Key information

Conditions

Neovascular(Wet) Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

    Time frame: Baseline to 3 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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