Clinical trial NCT04857177: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular(Wet) Age Related Macular Degeneration
Keywords: Neovascular(wet) Age related Macular Degeneration
CKD-701
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 312
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Mean change in the best-corrected visual acuity (BCVA) score from baseline to 3 months, 6 months and 12 months
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: 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
timeFrame: Baseline, 6 months, 12 months
measure: 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
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in the Central Retinal Thickness(CRT) at 1 months, 3 months, 6 months, 12months versus baseline
timeFrame: Baseline, 1 months, 3 months, 6 months, 12 months
measure: The proportion of patients with the absence of intraretinal fluid and subretinal fluid at 3 months, 6 months, 12months versus baseline
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyeong Gon Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: