Status:
COMPLETED
A Study To Evaluate CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Neovascular(Wet) Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 Lucent...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2021
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT04857177
Start Date
October 19 2018
End Date
March 17 2021
Last Update
April 23 2021
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea