Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).

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

Details

• Lead Sponsor: Lupin Ltd.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

1. Ambulatory male or female participants with age ≥ 50 years at the time of screening

2. Capable of understanding and giving written informed consent

3. Primary or recurrent (anti-VEGF naïve) active CNV lesions involving the foveal center secondary to AMD

4. BCVA between 20/40 and 20/200 (Snellen equivalent) in the study eye, using ETDRS testing

5. Willingness and ability to undertake all scheduled visits and assessments

Exclusion Criteria:

1. Known hypersensitivity to ranibizumab or any of the components of study medication

2. Known history of allergy to fluorescein dye

3. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye

4. Subretinal hemorrhage in the study eye that involves the center of the fovea

5. Uncontrolled glaucoma

6. Use of prohibited treatments

Other In-/Exclusion criteria may apply