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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Neovascular(Wet) Age Related Macular Degeneration

Intervention / Treatment
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* Drug: CKD-701
* Drug: Lucentis®


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-701<br>Drug: CKD-701 (proposed ranibizumab biosimilar) | Drug: CKD-701<br>* 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.<br>|
| Active Comparator: Lucentis®<br>Drug: Lucentis® (ranibizumab) | Drug: Lucentis®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascular(wet) Age related Macular Degeneration, CKD-701