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

• Status: Completed
• Trial end date: 2021-03-17
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Ranibizumab

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)