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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-22

Study Completion Date

2015-11-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ranibizumab 0.5 mg monthly

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

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Intravitreal injections of 0.5 mg Ranibizumab

Ranibizumab 0.5 mg pro re nata (PRN)

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

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Intravitreal injections of 0.5 mg Ranibizumab

Interventions

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Ranibizumab

Intravitreal injections of 0.5 mg Ranibizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with visual impairment due to neovascular AMD

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No