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

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Neovascular(Wet) Age Related Macular Degeneration

Treatments: Drug: CKD-701; Drug: Lucentis®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04857177

177AMD17019

Details and patient eligibility

About

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

Full 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.

Enrollment: 312 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

312 participants in 2 patient groups

CKD-701

Experimental group

Description:

Drug: CKD-701 (proposed ranibizumab biosimilar)

Treatment:

Drug: CKD-701

Lucentis®

Active Comparator group

Description:

Drug: Lucentis® (ranibizumab)

Treatment:

Drug: Lucentis®