MedTrace Logo

Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)

NCT01976312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2017-05-30

Study results available
· View outcomes & findings →

Summary

Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO

Conditions

  • Central Retinal Vein Occlusion

Interventions

OTHER

Sham injection

Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.

DRUG

Ranibizumab 0.5 mg

Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-12
Primary Completion
2016-03-14
Completion
2016-03-14

Countries

  • China
  • Hong Kong
  • India
  • Indonesia
  • Philippines
  • Taiwan
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976312 on ClinicalTrials.gov