Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration) (DRAGON)

Novartis

Status and phase: Completed; Phase 4

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01775124

CRFB002A2413

Details and patient eligibility

About

The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.

Enrollment: 332 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion criteria:

• Patients with visual impairment due to neovascular AMD
• A qualifying vision score at study entry Key Exclusion criteria
• Active infection or inflammation either eye at study entry
• Uncontrolled glaucoma in either eye
• Any disorder in the study eye which may affect vision
• Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3 months prior to study entry
• Previous treatment of the study eye for wet AMD
• Any surgery in the study eye 3 months prior to or planned with 6 month after study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

332 participants in 2 patient groups

Ranibizumab 0.5 mg monthly

Experimental group

Description:

Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period

Treatment:

Drug: Ranibizumab

Ranibizumab 0.5 mg pro re nata (PRN)

Experimental group

Description:

PRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period

Treatment:

Drug: Ranibizumab